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510(k) Data Aggregation

    K Number
    K965162
    Device Name
    LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
    Manufacturer
    LUKENS MEDICAL CORP.
    Date Cleared
    1997-02-12

    (50 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUKENS MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is in general soft tissue approximation and/or ligation including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
    Device Description
    Lukens® · PGA (polyglycolic acid), synthetic absorbable surgical sutures, coated, braided USP manufactured by Lukens Medical Corporation are equivalent to Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system manufactured by Davis & Geck. Lukens - PGA (polyglycolic acid), synthetic absorbable surgical sutures USP are dyed with D&C Violet No. 2 and are coated with E-Caprolactone.
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