BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SHIELD DISP. REINFORCED DRAPE SHEETS

    K Number: K800817 · Decision May 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    19
    Review Days
    21

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    Basic Information

    Device Name
    SHIELD DISP. REINFORCED DRAPE SHEETS
    K Number
    K800817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    April 11, 1980
    Decision Date
    May 2, 1980
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by American Convertors Div., American Pharmaseal

    K Number Device Name
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    K820994 ABSORB FURN SHEET
    K813419 COMFORT CUSHION DRY BURN PAD III
    K813296 CONVERTORS STERILE DISP. LAP SPONGE II
    K813078 CONTURA DISPOS. SURG. FACE MASK
    K812554 TOMAC STERILE DISP. LAP SPONGE
    K802919 ISO-BAC INSTRUMENT WRAP
    K802998 PATIENT CARE DISPOSABLE INFANT SHIRTS
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