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

    TECNOL HYDROGEL WOUND DRESSING

    K Number: K955575 · Decision Jan 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    21
    Review Days
    41

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    Basic Information

    Device Name
    TECNOL HYDROGEL WOUND DRESSING
    K Number
    K955575
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Tecnol Medical Products, Inc.
    Date Received
    December 7, 1995
    Decision Date
    January 17, 1996
    Product Code
    MGQ
    Advisory Committee
    Unknown
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Tecnol Medical Products, Inc.

    K Number Device Name
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    K970448 PCM 2000; ISOLAIR APR MODEL 2735
    K963559 WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
    K963564 PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
    K963552 QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
    K963773 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
    K963561 ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
    K963563 ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
    K963556 SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
    K963554 24448-010 SECURE-ALL FINGER CONTROL MITT
    Search all 21 clearances from Tecnol Medical Products, Inc. →