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

    FRASTEC DRY GAUZE BANDAGE

    K Number: K871917 · Decision Jun 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    23
    Review Days
    29

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    Basic Information

    Device Name
    FRASTEC DRY GAUZE BANDAGE
    K Number
    K871917
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Fraass Survival Systems, Inc.
    Date Received
    May 18, 1987
    Decision Date
    June 16, 1987
    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
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    Other Clearances by Fraass Survival Systems, Inc.

    K Number Device Name
    K912022 FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
    K871437 SURVIVAL KIT, INDIVIDUAL
    K871434 MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S
    K871458 SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW
    K871916 FRASTEC DRY BURN DRESSING
    K871376 FIRST AID KIT, VARIOUS SIZES
    K871501 KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE
    K871457 FIRST AID KIT, EYE DRESSING
    K871438 BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
    K870240 COMPRESS AND SKULLCAP, HEAD DRESSING
    Search all 23 clearances from Fraass Survival Systems, Inc. →