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

    SIMAR, INC. SURGICAL DRESSING

    K Number: K970020 · Decision Mar 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    SIMAR, INC. SURGICAL DRESSING
    K Number
    K970020
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Simar, Inc.
    Date Received
    January 3, 1997
    Decision Date
    March 20, 1997
    Product Code
    EFQ
    Advisory Committee
    Unknown
    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
    EFQ Gauze/Sponge, Internal

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