{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "San Diego",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "6199 Cornerstone Ct. E.",
      "address_2": "Suite 106",
      "statement_or_summary": "Summary",
      "product_code": "OCL",
      "openfda": {
        "device_name": "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2",
        "registration_number": [
          "1047843",
          "3008729892",
          "2182291",
          "1036836",
          "1721983",
          "2184009",
          "9616793",
          "1721676",
          "2954783",
          "3035387162",
          "3011706110",
          "3005012805",
          "3006451981",
          "2528981",
          "9616065",
          "1717344",
          "2133810",
          "1423662",
          "3008592544",
          "1319639",
          "2134265",
          "3009882464",
          "2028523",
          "2124215",
          "3008262715",
          "3026612481",
          "3018094310",
          "9611854",
          "2087259",
          "3003955307",
          "1928237"
        ],
        "fei_number": [
          "1047843",
          "2182291",
          "1036836",
          "1721676",
          "3035387162",
          "3011706110",
          "3005012805",
          "3006451981",
          "2528981",
          "1717344",
          "3008592544",
          "3000203066",
          "3003186357",
          "3009882464",
          "1000531402",
          "3002843919",
          "3002095335",
          "1000138054",
          "3008262715",
          "3026612481",
          "2124215",
          "3018094310",
          "3002807258",
          "3003381355",
          "3000215273",
          "1000116158",
          "1000125147",
          "1000064530",
          "3002807555",
          "3003955307",
          "1928237"
        ]
      },
      "zip_code": "92121",
      "applicant": "Cryogen, Inc.",
      "decision_date": "1998-02-03",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CRYOGEN CARDIAC CRYOSURGICAL SYSTEM",
      "advisory_committee": "SU",
      "contact": "CHERYL L SHEA",
      "expedited_review_flag": "",
      "k_number": "K974320",
      "state": "CA",
      "date_received": "1997-11-17",
      "review_advisory_committee": "CV",
      "postal_code": "92121",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}