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

    DISP. FENESTRATED SURG. DRAPE SHEETS

    K Number: K802359 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    19
    Review Days
    35

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    Basic Information

    Device Name
    DISP. FENESTRATED SURG. DRAPE SHEETS
    K Number
    K802359
    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
    September 26, 1980
    Decision Date
    October 31, 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
    K840957 ANTIMICROBIAL INCISE DRAPE
    K832137 CONVERTORS FLASH STERILIZING TRAY
    K830786 DISIMETRIC RELEASE OF INSTRANETICS RAD
    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
    Search all 19 clearances from American Convertors Div., American Pharmaseal →