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

    G-TUBE DRESSING CHANGE TRAY

    K Number: K905123 · Decision Mar 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    23
    Applicant Total
    8
    Review Days
    133

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    Basic Information

    Device Name
    G-TUBE DRESSING CHANGE TRAY
    K Number
    K905123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5075
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Continental Medical Laboratories, Inc.
    Date Received
    November 14, 1990
    Decision Date
    March 27, 1991
    Product Code
    MCY
    Advisory Committee
    General Hospital
    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
    MCY Wound Dressing 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
    K962073 URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
    K952335 WOUND CARE MANAGEMENT KITS