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

    ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID

    K Number: K040282 · Decision Apr 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    10
    Review Days
    83

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    Basic Information

    Device Name
    ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
    K Number
    K040282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Internacional Farmaceutica, S.A. DE C.V.
    Date Received
    February 6, 2004
    Decision Date
    April 29, 2004
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Internacional Farmaceutica, S.A. DE C.V.

    K Number Device Name
    K072859 ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
    K072863 ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
    K041048 POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K913185 STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
    K911354 STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
    K911189 STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
    K905287 IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES
    K905286 IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES
    K905285 IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES