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

    CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS

    K Number: K964041 · Decision Jan 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    2
    Review Days
    114

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    Basic Information

    Device Name
    CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
    K Number
    K964041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Robert R. Stevens
    Date Received
    October 8, 1996
    Decision Date
    January 30, 1997
    Product Code
    KOC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOC Accessories, Blood Circuit, Hemodialysis

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    Other Clearances by Robert R. Stevens

    K Number Device Name
    K955270 TAPE & BANDAGE, ADHESIVE