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

    POLYESTER X-RAY DETECTABLE STRUNG-SPONGE

    K Number: K830201 · Decision Feb 23, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    33
    Review Days
    34

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    Basic Information

    Device Name
    POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
    K Number
    K830201
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Medical Disposable, Inc.
    Date Received
    January 20, 1983
    Decision Date
    February 23, 1983
    Product Code
    GDY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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    Other Clearances by American Medical Disposable, Inc.

    K Number Device Name
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    K833731 BREATHABLE OVERWRAY BANDAGE NON-ELAS
    K833729 ELASTIC BREATHABLE OVER-WRAP BANDAGE
    K833733 NON - ADHERENT BANDAGE
    K833732 NON WETTING UNDERCAST PADDING
    K830202 COTTON BALLS, X-RAY OPAQUED STRUNG & NON
    K803116 HEAVY DRAINAGE PACK
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