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

    PETERS CARDIONYL(TM) SUTURE

    K Number: K913102 · Decision Aug 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    388

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    Basic Information

    Device Name
    PETERS CARDIONYL(TM) SUTURE
    K Number
    K913102
    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
    Promedica Products, Inc.
    Date Received
    July 12, 1991
    Decision Date
    August 3, 1992
    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 Promedica Products, Inc.

    K Number Device Name
    K913101 PETERS CARDIOFLON(TM) SUTURE
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    K883412 THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
    K882882 C-MASK
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