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

    AMER. V. MUELLER SURG. STAPLES ILA

    K Number: K833698 · Decision Jan 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    13
    Review Days
    71

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    Basic Information

    Device Name
    AMER. V. MUELLER SURG. STAPLES ILA
    K Number
    K833698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Heyer Schulte
    Date Received
    November 15, 1983
    Decision Date
    January 25, 1984
    Product Code
    GDW
    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
    GDW Staple, Implantable

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    K833704 AMER. V. MUELLER SURGICALSTAPLES-CARTR
    K832738 HEYER-SCHULTE AFTERLOADING CATHETER
    K823790 VENTRICULAR ACCESS SYSTEM
    K822096 CHEMOTHERAPY INFUSION CATHETER
    K822032 LARGE VOLUME CLOSED WOUND SUCTION DRAIN
    K820247 EXTERNAL VENTRICULAR DRAINAGE SYS.
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