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

    WHITE PLUME GAUZE SPONGE

    K Number: K870314 · Decision Feb 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    12
    Review Days
    27

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    Basic Information

    Device Name
    WHITE PLUME GAUZE SPONGE
    K Number
    K870314
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    China National Medicines & Health Prod. I/E Corp.
    Date Received
    January 28, 1987
    Decision Date
    February 24, 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

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    Other Clearances by China National Medicines & Health Prod. I/E Corp.

    K Number Device Name
    K902324 TP AND DESIGN, CONDOM
    K893351 LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX)
    K892916 PATIENT EXAMINATION GLOVES (LATEX)
    K891365 LATEX EXAMINATION GLOVES, NON-STERILE
    K870306 WHITE PLUME TRIANGULAR BANDAGE
    K870309 WHITE PLUME ABSORBENT COTTON WOOL
    K870312 WHITE PLUME SURGICAL GAUZE FACE MASK
    K870308 WHITE PLUME ABSORBENT GAUZE
    K870315 WHITE PLUME ABSORBENT BANDAGE
    K870310 VSID MEDICAL THREE-FOLDING BED
    Search all 12 clearances from China National Medicines & Health Prod. I/E Corp. →