BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICROSCOPE DRAPE

    K Number: K902851 · Decision Sep 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    MICROSCOPE DRAPE
    K Number
    K902851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Technique Instruments, Inc.
    Date Received
    June 29, 1990
    Decision Date
    September 10, 1990
    Product Code
    HMW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HMW Drape, Microscope, Ophthalmic

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    Other Clearances by Medical Technique Instruments, Inc.

    K Number Device Name
    K893728 PINK CASSETTE CADDIE