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

    WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER

    K Number: K935505 · Decision Feb 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    18
    Review Days
    79

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    Basic Information

    Device Name
    WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
    K Number
    K935505
    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 3, 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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    Other Clearances by Kawasumi Laboratories Co., Ltd.

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    K935514 VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
    K935506 MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
    K930012 KAWASUMI LABORATORIES K-CUFF
    K921901 PORT ACCESS INFUSION SET
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