BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER

    K Number: K935514 · Decision Feb 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    18
    Review Days
    86

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    Basic Information

    Device Name
    VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
    K Number
    K935514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories Co., Ltd.
    Date Received
    November 16, 1993
    Decision Date
    February 10, 1994
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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    K935506 MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
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    K930012 KAWASUMI LABORATORIES K-CUFF
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