BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IDENTI-LOOPS

    K Number: K780720 · Decision Oct 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    2
    Review Days
    169

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    Basic Information

    Device Name
    IDENTI-LOOPS
    K Number
    K780720
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Berkeley Bio-Medical, Inc.
    Date Received
    May 1, 1978
    Decision Date
    October 17, 1978
    Product Code
    GAD
    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
    GAD Retractor

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    Other Clearances by Berkeley Bio-Medical, Inc.

    K Number Device Name
    K780721 IDENTI-CLAMPS