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

    CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING

    K Number: K946338 · Decision Mar 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    17
    Review Days
    90

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    Basic Information

    Device Name
    CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
    K Number
    K946338
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Certified Safety Mfg., Inc.
    Date Received
    December 29, 1994
    Decision Date
    March 29, 1995
    Product Code
    MGP
    Advisory Committee
    Unknown
    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
    MGP Dressing, Wound And Burn, Occlusive

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    K941311 FIRST AID/TRUMA KIT
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