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

    GENT-L-KARE TRACHEOSTOMY TRAYS

    K Number: K950851 · Decision Jun 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    5
    Applicant Total
    9
    Review Days
    117

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    GENT-L-KARE TRACHEOSTOMY TRAYS
    K Number
    K950851
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Premium Plastics, Inc.
    Date Received
    February 24, 1995
    Decision Date
    June 21, 1995
    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.

    TRACHEOSTOMY KIT

    FDA 510(k)
    FDA Class 1 ·Unknown

    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

    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 Premium Plastics, Inc.

    K Number Device Name
    K953226 PULM O2 SUCTION CATHETER TRAYS
    K950850 GENT-L-KARE LACERATION TRAYS
    K943740 ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
    K890107 GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
    K893135 GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
    K850285 GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
    K800440 STERILE SPONGE BOWLS
    K771448 STERILE SUTURE REMOVAL KIT