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

    OMED DISPOSABLE BULLDOG

    K Number: K813499 · Decision Dec 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    9
    Review Days
    15

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    Basic Information

    Device Name
    OMED DISPOSABLE BULLDOG
    K Number
    K813499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Omega-Med Intl., Inc.
    Date Received
    December 14, 1981
    Decision Date
    December 29, 1981
    Product Code
    DXC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXC Clamp, Vascular

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    Other Clearances by Omega-Med Intl., Inc.

    K Number Device Name
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    K822284 COMPLY NEUROMUSCULAR STIMULATOR
    K821334 OMED FABRIC INSTRUMENT COVERS-RADIOPAQ
    K810883 OMED SILICONE INSTRUMENT COVERS
    K810269 OMED FABRIC INSTRUMENT COVERS
    K810260 OMED SILICONE LOOPS