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

    GRAMS SILK NONABSORBABLE SUTURE

    K Number: K003001 · Decision Dec 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    40
    Applicant Total
    7
    Review Days
    80

    Basic Information

    Device Name
    GRAMS SILK NONABSORBABLE SUTURE
    K Number
    K003001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GRAMSMED LLC
    Date Received
    September 26, 2000
    Decision Date
    December 15, 2000
    Product Code
    GAP
    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
    GAP Suture, Nonabsorbable, Silk

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    Other Clearances by GRAMSMED LLC

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    K021043 GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
    K010672 MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
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    K002999 GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
    K003000 GRAMS NYLON NONABSORBABLE SUTURE