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

    PROD NO. 01-1694 - 4X4 FOAM DRESSING

    K Number: K954728 · Decision Sep 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    8
    Review Days
    346

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    Basic Information

    Device Name
    PROD NO. 01-1694 - 4X4 FOAM DRESSING
    K Number
    K954728
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Continental Medical Laboratories, Inc.
    Date Received
    October 13, 1995
    Decision Date
    September 23, 1996
    Product Code
    KMF
    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
    KMF Bandage, Liquid

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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
    K962073 URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
    K952335 WOUND CARE MANAGEMENT KITS
    K905123 G-TUBE DRESSING CHANGE TRAY