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

    ADVANCE SUTURE ABSORBABLE GUT SUTURE

    K Number: K903174 · Decision Jul 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    357

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    Basic Information

    Device Name
    ADVANCE SUTURE ABSORBABLE GUT SUTURE
    K Number
    K903174
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Advance Suture, Inc.
    Date Received
    July 18, 1990
    Decision Date
    July 10, 1991
    Product Code
    GAE
    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
    GAE Snare, Surgical

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