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

    SYNTEC, INC. DISPOSABLE BARE END FIBER

    K Number: K971338 · Decision May 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    3
    Review Days
    26

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    Basic Information

    Device Name
    SYNTEC, INC. DISPOSABLE BARE END FIBER
    K Number
    K971338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntec, Inc.
    Date Received
    April 10, 1997
    Decision Date
    May 6, 1997
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPA Endoilluminator

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    Other Clearances by Syntec, Inc.

    K Number Device Name
    K002932 PHACOGARD
    K980480 SYNTEC VITMAN