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

    PHYNE-VU

    K Number: K885096 · Decision Jul 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    228

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    Basic Information

    Device Name
    PHYNE-VU
    K Number
    K885096
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Medical Resources, Ltd.
    Date Received
    December 9, 1988
    Decision Date
    July 25, 1989
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Medical Resources, Ltd.

    K Number Device Name
    K931250 PHYNE-TOUCH PF
    K914628 PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF
    K903559 HIGH RISK
    K895195 CHEMO-TOUCH
    K894212 PHYNE-TOUCH-STERILE
    K890983 PHYNE-TOUCH (PATIENT EXAMINATION GLOVES)