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

    MEROCEL WOUND DRESSING

    K Number: K931565 · Decision Aug 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    10
    Review Days
    129

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    Basic Information

    Device Name
    MEROCEL WOUND DRESSING
    K Number
    K931565
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Merocel Corp.
    Date Received
    March 30, 1993
    Decision Date
    August 6, 1993
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

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    Other Clearances by Merocel Corp.

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    K943718 EPISTAT-II NASAL CATHETER
    K940572 MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)
    K935658 MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
    K933152 MEROCEL MEROSPLINT
    K920394 MEROCEL EPISTACIS KIT
    K910463 MEROCEL(R) LASER-GUARD(TM)