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

    ALBA HEALTH CARE PLAIN PACKING STRIP

    K Number: K861154 · Decision Apr 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    8
    Review Days
    18

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    Basic Information

    Device Name
    ALBA HEALTH CARE PLAIN PACKING STRIP
    K Number
    K861154
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Alba Health Care
    Date Received
    March 28, 1986
    Decision Date
    April 15, 1986
    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

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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 Alba Health Care

    K Number Device Name
    K864689 ALBA HEALTH CARE IODOFORM PACKING STRIP
    K851918 INFANT PHOTOTHERAPY MASK
    K850881 ALBA DRY BURN PAD
    K850904 ALBA DRY BURN DRESSING
    K850241 ALBA HEALTH CARE NON-ADHERING DRESSING
    K812904 STERILE ORTHOPEDIC STOCKINETTE
    K803171 PROCEDURE & RECOVERY PATIENT SUIT