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

    SPONGE COUNTER BAGS

    K Number: K791434 · Decision Oct 9, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    66
    Applicant Total
    7
    Review Days
    70

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    Basic Information

    Device Name
    SPONGE COUNTER BAGS
    K Number
    K791434
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medicare Industries, Inc.
    Date Received
    July 31, 1979
    Decision Date
    October 9, 1979
    Product Code
    KDC
    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
    KDC Instrument, Surgical, Disposable

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    DISPOSABLE SURGICAL SCISSORS AND FORCEPS

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    SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET

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    THERMUFF BAG

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    MANUAL SURGICAL INSTRUMENTS

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    DISPOSABLE CAUTERY ABRASIVE PAD

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    INSTRUMENT ORGANIZER

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    Other Clearances by Medicare Industries, Inc.

    K Number Device Name
    K894197 LATEX EXAMINATION GLOVES
    K891865 NIL (PATIENT EXAMINATION GLOVES - LATEX)
    K781980 RESPIRATORY THERAPY GAS POUCH
    K781981 DECONTAMINATION ITEMS BAG
    K781925 POUCHES, GAS STERILIZATION
    K781924 POUCHES AND TUBING, MEDI-SEAL