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

    MEROCEL VAGINAL PACK

    K Number: K953072 · Decision Sep 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    10
    Review Days
    74

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MEROCEL VAGINAL PACK
    K Number
    K953072
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merocel Corp.
    Date Received
    June 30, 1995
    Decision Date
    September 12, 1995
    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

    FDA 510(k)
    FDA Unclassified ·Unknown

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

    FDA 510(k)
    FDA Unclassified ·Unknown

    VITOP DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

    FDA 510(k)
    FDA Unclassified ·Unknown

    CROSSTEX NON-WOVEN SPONGES

    FDA 510(k)
    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Merocel Corp.

    K Number Device Name
    K954919 MEROCEL SOFT WOUND DRESSING
    K953013 MEROCEL REINFORCED SILICONE SHEETS
    K943718 EPISTAT-II NASAL CATHETER
    K940572 MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)
    K935658 MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
    K933152 MEROCEL MEROSPLINT
    K931565 MEROCEL WOUND DRESSING
    K920394 MEROCEL EPISTACIS KIT
    K910463 MEROCEL(R) LASER-GUARD(TM)