BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SLIMCATH (TM)

    K Number: K903001 · Decision Jun 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    351

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    Basic Information

    Device Name
    SLIMCATH (TM)
    K Number
    K903001
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Gynopharma, Inc.
    Date Received
    July 9, 1990
    Decision Date
    June 25, 1991
    Product Code
    HIT
    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
    HIT Tester, Color Vision

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    Other Clearances by Gynopharma, Inc.

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