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

    URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY

    K Number: K962073 · Decision Jun 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    8
    Review Days
    24

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    Basic Information

    Device Name
    URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
    K Number
    K962073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Continental Medical Laboratories, Inc.
    Date Received
    May 28, 1996
    Decision Date
    June 21, 1996
    Product Code
    FCM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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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
    K962078 TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
    K954728 PROD NO. 01-1694 - 4X4 FOAM DRESSING
    K952335 WOUND CARE MANAGEMENT KITS
    K905123 G-TUBE DRESSING CHANGE TRAY