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

    HEAVY DRAINAGE PACK

    K Number: K803116 · Decision Jan 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    36
    Applicant Total
    33
    Review Days
    49

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    Basic Information

    Device Name
    HEAVY DRAINAGE PACK
    K Number
    K803116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Medical Disposable, Inc.
    Date Received
    December 10, 1980
    Decision Date
    January 28, 1981
    Product Code
    GEC
    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
    GEC Brush, Scrub, Operating-Room

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    Other Clearances by American Medical Disposable, Inc.

    K Number Device Name
    K833734 NEUROLOGICAL SPONGE ON PLASTIC STICK
    K833735 AN ODOR ABSORBENT BANDAGE
    K833730 NON ADHERENT BANDAGE/SHEET
    K833731 BREATHABLE OVERWRAY BANDAGE NON-ELAS
    K833729 ELASTIC BREATHABLE OVER-WRAP BANDAGE
    K833733 NON - ADHERENT BANDAGE
    K833732 NON WETTING UNDERCAST PADDING
    K830201 POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
    K830202 COTTON BALLS, X-RAY OPAQUED STRUNG & NON
    K803115 DRESSING CHANGE FOR G TUBE
    Search all 33 clearances from American Medical Disposable, Inc. →