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

    PETERS CARDIOFLON(TM) SUTURE

    K Number: K913101 · Decision Aug 12, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    16
    Applicant Total
    6
    Review Days
    397

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    Basic Information

    Device Name
    PETERS CARDIOFLON(TM) SUTURE
    K Number
    K913101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promedica Products, Inc.
    Date Received
    July 12, 1991
    Decision Date
    August 12, 1992
    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 Promedica Products, Inc.

    K Number Device Name
    K913102 PETERS CARDIONYL(TM) SUTURE
    K892768 PATIENT EXAMINATION GLOVES (POLY)
    K883412 THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
    K882882 C-MASK
    K882883 C-MASK(FLAT)