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

    INAMED PRO-TEC SILICONE SURGICAL GLOVES

    K Number: K894073 · Decision Sep 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    7
    Review Days
    102

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    Basic Information

    Device Name
    INAMED PRO-TEC SILICONE SURGICAL GLOVES
    K Number
    K894073
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Inamed Development Co.
    Date Received
    June 8, 1989
    Decision Date
    September 18, 1989
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by Inamed Development Co.

    K Number Device Name
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    K901742 INAMED SMALL DRAIN SYSTEM
    K901764 INAMED CONVERTIBLE DRAIN SYSTEM
    K894618 INAMED RHEMO-D (TM) DILATOR
    K896491 INAMED CLOSED-WOUND DRAIN SYSTEM