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

    AWC BUTTERFLY WOUND CLOSURES

    K Number: K894802 · Decision Jan 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    187

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    Basic Information

    Device Name
    AWC BUTTERFLY WOUND CLOSURES
    K Number
    K894802
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American White Cross, Inc.
    Date Received
    July 28, 1989
    Decision Date
    January 31, 1990
    Product Code
    FPX
    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
    FPX Strip, Adhesive, Closure, Skin

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    Other Clearances by American White Cross, Inc.

    K Number Device Name
    K964614 ULTRAFERA WOUND DRESSING
    K962400 AIR MAX EXTERNAL NASAL DILATOR STRIP
    K854809 WHITE CROSS STERILE PAD 4IN. X 4IN.
    K853558 DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
    K853334 NON-ADHERA ADHESIVE PAD 3X4
    K852408 EXTRA LARGE ADHESIVE STRIPS
    K852412 NON-ADHERENT PAD
    K852462 TRICOT ADHESIVE BANDAGE
    K850595 3 X 4 NON-ADHERENT PAD