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

    CRYOCYTE PACK

    K Number: K780354 · Decision Jun 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    15
    Applicant Total
    206
    Review Days
    103

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    Basic Information

    Device Name
    CRYOCYTE PACK
    K Number
    K780354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    March 3, 1978
    Decision Date
    June 14, 1978
    Product Code
    KSR
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

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