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

    PATIENT CARE DISPOSABLE INFANT SHIRTS

    K Number: K802998 · Decision Dec 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    64
    Applicant Total
    19
    Review Days
    27

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PATIENT CARE DISPOSABLE INFANT SHIRTS
    K Number
    K802998
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6060
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    November 25, 1980
    Decision Date
    December 22, 1980
    Product Code
    KME
    Advisory Committee
    General Hospital
    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
    KME Bedding, Disposable, Medical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KME), ordered by most recent decision date.

    READY-HEAT BLANKET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OREX MEDICAL BEDDING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DISPOSE-A-SHEET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DOCTOR DOWN --RESCUE WRAP

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AMERICAN BURN SHEET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FOIL BABY BUNTING

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    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
    K802359 DISP. FENESTRATED SURG. DRAPE SHEETS
    Search all 19 clearances from American Convertors Div., American Pharmaseal →