BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PGA RESORBA, PGA RESOQUICK, GLYCOLON

    K Number: K143584 · Decision Nov 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    4
    Review Days
    319

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    Basic Information

    Device Name
    PGA RESORBA, PGA RESOQUICK, GLYCOLON
    K Number
    K143584
    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
    Resorba Medical GmbH
    Date Received
    December 18, 2014
    Decision Date
    November 2, 2015
    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 Resorba Medical GmbH

    K Number Device Name
    K181320 Caprolon
    K143582 MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
    K141072 SUPOLENE