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

    TECNOL VARIABLE TENSION BANDAGE

    K Number: K884440 · Decision Jan 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    35
    Review Days
    88

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    Basic Information

    Device Name
    TECNOL VARIABLE TENSION BANDAGE
    K Number
    K884440
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Tecnol New Jersey Wound Care, Inc.
    Date Received
    October 21, 1988
    Decision Date
    January 17, 1989
    Product Code
    NAD
    Advisory Committee
    General, Plastic Surgery
    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
    NAD Dressing, Wound, Occlusive

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    Other Clearances by Tecnol New Jersey Wound Care, Inc.

    K Number Device Name
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    K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
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    K894205 TECNOL SILK STRIP
    K893702 TECNOL GAITERS PRODUCT NUMBER 47725-010
    K891187 TECNOL NASO-GASTRIC TUBE HOLDER
    K891178 TECNOL SECURE-ALL TUBE HOLDER
    K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT
    K882641 TECNOL CATHETER LEG STRAP
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