{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Sturbridge",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "P.O. Box 225, Rte. 20/49",
      "address_2": "Techno Park Rd.",
      "statement_or_summary": "",
      "product_code": "FSP",
      "openfda": {
        "registration_number": [
          "3003807268",
          "3005515469",
          "2431166",
          "3023808059",
          "3026312050",
          "1927430",
          "3011554142",
          "8010427",
          "3015895045",
          "9616250",
          "1836161",
          "3015136927",
          "3023194894",
          "1926681",
          "3011778089",
          "3009768364",
          "3008860098",
          "3011279497",
          "3013403214",
          "3014268446",
          "1720747",
          "3042172872",
          "3001644167",
          "2126670",
          "3006799849",
          "3014683120",
          "3003848022",
          "9610612",
          "3004513872",
          "3026861828",
          "3042989733",
          "3016875543",
          "3014414462",
          "8010482",
          "2127132",
          "3022320321",
          "3003969012",
          "1412854",
          "3015316279",
          "2431764",
          "3044150131",
          "3006697692",
          "2916714",
          "3006550126",
          "3025436467",
          "2434008",
          "1051614",
          "3023388535",
          "3014326245",
          "9616704",
          "8021788",
          "3011215096",
          "1645452",
          "3025376090",
          "3007597038",
          "3036269993",
          "3031582434",
          "3016891393",
          "3002821232",
          "8030607"
        ],
        "fei_number": [
          "3003807268",
          "3005515469",
          "3023808059",
          "3026312050",
          "1927430",
          "3011554142",
          "3015895045",
          "1000139591",
          "1000347621",
          "3015136927",
          "3000302881",
          "3023194894",
          "3006509795",
          "1926681",
          "6034",
          "3011778089",
          "3009768364",
          "3008860098",
          "3011279497",
          "3013403214",
          "3014268446",
          "1720747",
          "3042172872",
          "3001644167",
          "2126670",
          "3006799849",
          "3014683120",
          "3003848022",
          "3004513872",
          "3026861828",
          "3042989733",
          "3016875543",
          "3014414462",
          "3022320321",
          "3003969012",
          "1412854",
          "3015316279",
          "2431764",
          "3044150131",
          "3003772581",
          "3006697692",
          "2916714",
          "3006550126",
          "3025436467",
          "2434008",
          "1051614",
          "3023388535",
          "2523865",
          "3014326245",
          "5682",
          "3011215096",
          "3002750084",
          "3002806315",
          "3025376090",
          "3036269993",
          "3031582434",
          "3016891393",
          "1000292048",
          "3002821232",
          "2127132"
        ],
        "device_name": "Loupe, Diagnostic/Surgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
        "device_class": "1"
      },
      "zip_code": "01566",
      "applicant": "Luxtec Corp.",
      "decision_date": "1986-11-17",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "LUXTEC LOUPES FOR SURGICAL VISION",
      "advisory_committee": "SU",
      "contact": "THOMAS  WILK",
      "expedited_review_flag": "",
      "k_number": "K864386",
      "state": "MA",
      "date_received": "1986-11-05",
      "review_advisory_committee": "SU",
      "postal_code": "01566",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}