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

    TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER

    K Number: K962078 · Decision Oct 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    8
    Review Days
    136

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    Basic Information

    Device Name
    TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
    K Number
    K962078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Continental Medical Laboratories, Inc.
    Date Received
    May 28, 1996
    Decision Date
    October 11, 1996
    Product Code
    JOH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Continental Medical Laboratories, Inc.

    K Number Device Name
    K964827 PROD. NO. 01-132 - SUTURE REMOVAL KIT
    K963234 STAPLE REMOVAL KIT
    K963443 PROD. NO. 02-031 - LACERATION TRAY
    K954728 PROD NO. 01-1694 - 4X4 FOAM DRESSING
    K962073 URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
    K952335 WOUND CARE MANAGEMENT KITS
    K905123 G-TUBE DRESSING CHANGE TRAY