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

    PHARMAFLEX CRYOGENIC BAG

    K Number: K792395 · Decision Feb 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    92

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    Basic Information

    Device Name
    PHARMAFLEX CRYOGENIC BAG
    K Number
    K792395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pharmachem Corp.
    Date Received
    November 26, 1979
    Decision Date
    February 26, 1980
    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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