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

    NON-ADHERENT PAD

    K Number: K852412 · Decision Jul 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    10
    Review Days
    53

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    Basic Information

    Device Name
    NON-ADHERENT PAD
    K Number
    K852412
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    American White Cross, Inc.
    Date Received
    June 6, 1985
    Decision Date
    July 29, 1985
    Product Code
    EFQ
    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
    EFQ Gauze/Sponge, Internal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.

    NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE

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    SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

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    VITOP DRESSING

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    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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    CROSSTEX NON-WOVEN SPONGES

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    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

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    FDA Unclassified ·Unknown
    View all

    Other Clearances by American White Cross, Inc.

    K Number Device Name
    K964614 ULTRAFERA WOUND DRESSING
    K962400 AIR MAX EXTERNAL NASAL DILATOR STRIP
    K894802 AWC BUTTERFLY WOUND CLOSURES
    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
    K852462 TRICOT ADHESIVE BANDAGE
    K850595 3 X 4 NON-ADHERENT PAD