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

    WOUND CARE MANAGEMENT KITS

    K Number: K952335 · Decision Jun 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    WOUND CARE MANAGEMENT KITS
    K Number
    K952335
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Continental Medical Laboratories, Inc.
    Date Received
    May 18, 1995
    Decision Date
    June 14, 1995
    Product Code
    LYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYY Latex Patient Examination Glove

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    K962078 TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
    K954728 PROD NO. 01-1694 - 4X4 FOAM DRESSING
    K962073 URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
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