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

    POST OPERATIVE SPONGE

    K Number: K912693 · Decision Oct 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    21
    Review Days
    108

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    Basic Information

    Device Name
    POST OPERATIVE SPONGE
    K Number
    K912693
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ulti-Med Intl., Inc.
    Date Received
    June 18, 1991
    Decision Date
    October 4, 1991
    Product Code
    NAB
    Advisory Committee
    General, Plastic Surgery
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

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    K Number Device Name
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    K920989 SURGICAL INSTRUMENT KIT, DISPOSABLE
    K922828 ULCER WOUND TRAY
    K914244 STERILE CUSTOM SURGICAL KITS
    K914431 ABSORBENT FIBER
    K912692 CONFORMING BANDAGE
    K904896 EYE PAD
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