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

    MODULAP

    K Number: K982445 · Decision Sep 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    MODULAP
    K Number
    K982445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atc Medical Technology, Inc.
    Date Received
    July 15, 1998
    Decision Date
    September 8, 1998
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Atc Medical Technology, Inc.

    K Number Device Name
    K800489 LASER BACKPOINTER ASSEMBLY, MOD. 01-2487