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

    TRACHEOSTOMY KIT

    K Number: K963720 · Decision Nov 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    5
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    TRACHEOSTOMY KIT
    K Number
    K963720
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Grand Medical Products
    Date Received
    September 16, 1996
    Decision Date
    November 27, 1996
    Product Code
    LRQ
    Advisory Committee
    Unknown
    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
    LRQ Tracheostomy And Nasal Suctioning Kit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LRQ), ordered by most recent decision date.

    MEDCARE TRACHEOSTOMY CARE TRAY

    FDA 510(k)
    FDA Class 1 ·Unknown

    READY NURSE SYSTEM (RNS) TRACH CARE KIT

    FDA 510(k)
    FDA Class 1 ·Unknown

    GENT-L-KARE TRACHEOSTOMY TRAYS

    FDA 510(k)
    FDA Class 1 ·Unknown

    TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1

    FDA 510(k)
    FDA Class 1 ·Unknown

    TRACHEOSTOMY CARE TRAY

    FDA 510(k)
    FDA Class 1 ·Unknown
    View all

    Other Clearances by Grand Medical Products

    K Number Device Name
    K963724 GAUZE SPONGE, NON X-RAY DETECTABLE
    K963715 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
    K963719 CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
    K963723 LACERATION TRAY
    K963714 GRAND MEDICAL SUTURE REMOVAL KIT
    K963721 SKIN SCRUB TRAY
    K963722 IV START KIT