BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LACERATION TRAY

    K Number: K963723 · Decision Nov 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    285
    Registration Numbers
    286
    Same Product Code
    21
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    LACERATION TRAY
    K Number
    K963723
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Grand Medical Products
    Date Received
    September 16, 1996
    Decision Date
    November 27, 1996
    Product Code
    LRP
    Advisory Committee
    General, Plastic Surgery
    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
    LRP Tray, Surgical

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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
    K963714 GRAND MEDICAL SUTURE REMOVAL KIT
    K963721 SKIN SCRUB TRAY
    K963722 IV START KIT