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

    SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE

    K Number: K931914 · Decision Oct 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    56
    Applicant Total
    7
    Review Days
    537

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    Basic Information

    Device Name
    SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE
    K Number
    K931914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgimetrics International, Ltd.
    Date Received
    April 16, 1993
    Decision Date
    October 5, 1994
    Product Code
    GAR
    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
    GAR Suture, Nonabsorbable, Synthetic, Polyamide

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    Other Clearances by Surgimetrics International, Ltd.

    K Number Device Name
    K931916 SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER
    K931915 STAINLESS STEEL SUTURE
    K931917 SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE
    K931918 CATGUT SUTURE PLAIN
    K931919 CATGUT SUTURE CHROMIC
    K931913 SUTURE NON-ABSORBABLE SILK