BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK

    K Number: K971473 · Decision Jul 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    36
    Applicant Total
    3
    Review Days
    75

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    Basic Information

    Device Name
    IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
    K Number
    K971473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    M-Pact Worldwide Management Corp.
    Date Received
    April 23, 1997
    Decision Date
    July 7, 1997
    Product Code
    GEC
    Advisory Committee
    General, Plastic Surgery
    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
    GEC Brush, Scrub, Operating-Room

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    Other Clearances by M-Pact Worldwide Management Corp.

    K Number Device Name
    K971832 IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
    K964113 IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL