BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ADVANCE SUTURE NONABSORBABLE DACRON SUTURE

    K Number: K903175 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    373

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    Basic Information

    Device Name
    ADVANCE SUTURE NONABSORBABLE DACRON SUTURE
    K Number
    K903175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Advance Suture, Inc.
    Date Received
    July 18, 1990
    Decision Date
    July 26, 1991
    Product Code
    GAS
    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
    GAS Suture, Nonabsorbable, Synthetic, Polyester

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    Other Clearances by Advance Suture, Inc.

    K Number Device Name
    K903174 ADVANCE SUTURE ABSORBABLE GUT SUTURE
    K903176 ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE
    K903177 ADVANCE SUTURE NONABSORBABLE NYLON SUTURE
    K905454 ADVANCE SUTURE NONABSORBABLE SILK SUTURE