BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES

    K Number: K903303 · Decision Oct 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    17
    Review Days
    79

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    Basic Information

    Device Name
    SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
    K Number
    K903303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Spembly Medical , Ltd.
    Date Received
    July 24, 1990
    Decision Date
    October 11, 1990
    Product Code
    HPS
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HPS Unit, Cryophthalmic

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    K882963 SPEMBLY MEDICAL 142 CRYO UNIT
    K874367 VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF
    K840497 OBSTETRIC PULSAR TWO CHANNEL TENS
    K832385 CRYOPROBES MC-1400-CRYOSURG-CONSOLE
    K832334 CRYOMEDICS 5000 CRYOSURGICAL CONSOLE
    K832140 CRYOMEDICS 5000 CRYOPROBES
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