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

    IV START KIT

    K Number: K963722 · Decision Nov 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    29
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    IV START KIT
    K Number
    K963722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Grand Medical Products
    Date Received
    September 16, 1996
    Decision Date
    November 27, 1996
    Product Code
    LRS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRS I.V. Start Kit

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    Other Clearances by Grand Medical Products

    K Number Device Name
    K963724 GAUZE SPONGE, NON X-RAY DETECTABLE
    K963715 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
    K963720 TRACHEOSTOMY KIT
    K963719 CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
    K963723 LACERATION TRAY
    K963714 GRAND MEDICAL SUTURE REMOVAL KIT
    K963721 SKIN SCRUB TRAY