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

    AILEE SUTURES AND AILEE NEEDLES

    K Number: K982646 · Decision Jun 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    29
    Applicant Total
    12
    Review Days
    308

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    Basic Information

    Device Name
    AILEE SUTURES AND AILEE NEEDLES
    K Number
    K982646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Myco Medical Supplies, Inc.
    Date Received
    July 29, 1998
    Decision Date
    June 2, 1999
    Product Code
    GAL
    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
    GAL Suture, Absorbable, Natural

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