BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    DISPOSABLE EXTERNAL CLAMPS

    K Number: K896383 · Decision Dec 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    274
    Registration Numbers
    274
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    DISPOSABLE EXTERNAL CLAMPS
    K Number
    K896383
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Galenica Enterprises, Inc.
    Date Received
    November 6, 1989
    Decision Date
    December 6, 1989
    Product Code
    GDI
    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
    GDI Dissector, Surgical, General & Plastic Surgery

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