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

    AN ODOR ABSORBENT BANDAGE

    K Number: K833735 · Decision Apr 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    33
    Review Days
    181

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    Basic Information

    Device Name
    AN ODOR ABSORBENT BANDAGE
    K Number
    K833735
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Medical Disposable, Inc.
    Date Received
    October 25, 1983
    Decision Date
    April 23, 1984
    Product Code
    NAB
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

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    Other Clearances by American Medical Disposable, Inc.

    K Number Device Name
    K833734 NEUROLOGICAL SPONGE ON PLASTIC STICK
    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
    K803116 HEAVY DRAINAGE PACK
    K803115 DRESSING CHANGE FOR G TUBE
    Search all 33 clearances from American Medical Disposable, Inc. →