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

    ASEPTIC TRANSFER SET

    K Number: K780417 · Decision Apr 18, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    206
    Same Product Code
    26
    Applicant Total
    9
    Review Days
    35

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    Basic Information

    Device Name
    ASEPTIC TRANSFER SET
    K Number
    K780417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Heyer Schulte Corp.
    Date Received
    March 14, 1978
    Decision Date
    April 18, 1978
    Product Code
    GAZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAZ Tubing, Noninvasive

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