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

    VAL-U-WRAP CSR WRAP

    K Number: K801569 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    19
    Review Days
    20

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    Basic Information

    Device Name
    VAL-U-WRAP CSR WRAP
    K Number
    K801569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    July 8, 1980
    Decision Date
    July 28, 1980
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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    Other Clearances by American Convertors Div., American Pharmaseal

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    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
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