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

    CUSTOM DRESSING TRAY-WET TO DRY/MASS.

    K Number: K802385 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    34
    Applicant Total
    33
    Review Days
    41

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    Basic Information

    Device Name
    CUSTOM DRESSING TRAY-WET TO DRY/MASS.
    K Number
    K802385
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Medical Disposable, Inc.
    Date Received
    October 2, 1980
    Decision Date
    November 12, 1980
    Product Code
    FPX
    Advisory Committee
    General Hospital
    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
    FPX Strip, Adhesive, Closure, Skin

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    Other Clearances by American Medical Disposable, Inc.

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    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
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