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

    BURN DRESSING

    K Number: K923846 · Decision Sep 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    8
    Review Days
    42

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    Basic Information

    Device Name
    BURN DRESSING
    K Number
    K923846
    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
    Medical Action Industries, Inc.
    Date Received
    July 31, 1992
    Decision Date
    September 11, 1992
    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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    Other Clearances by Medical Action Industries, Inc.

    K Number Device Name
    K042526 DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
    K042527 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    K022948 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
    K946019 SURGICLA INSTRUMENT KIT
    K884826 GAUZE SPONGE
    K810685 SUTURE REMOVAL KIT
    K810184 LAPAROTOMY SPONGE