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

    TECNOL BODY HOLDER

    K Number: K790699 · Decision Jun 1, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    133
    Applicant Total
    35
    Review Days
    50

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    Basic Information

    Device Name
    TECNOL BODY HOLDER
    K Number
    K790699
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tecnol New Jersey Wound Care, Inc.
    Date Received
    April 12, 1979
    Decision Date
    June 1, 1979
    Product Code
    FMQ
    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
    FMQ Restraint, Protective

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    Other Clearances by Tecnol New Jersey Wound Care, Inc.

    K Number Device Name
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    K911891 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
    K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
    K896193 TECNOL LAZER(TM) SURGICAL MASK
    K894205 TECNOL SILK STRIP
    K893702 TECNOL GAITERS PRODUCT NUMBER 47725-010
    K891187 TECNOL NASO-GASTRIC TUBE HOLDER
    K891178 TECNOL SECURE-ALL TUBE HOLDER
    K884440 TECNOL VARIABLE TENSION BANDAGE
    K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT
    Search all 35 clearances from Tecnol New Jersey Wound Care, Inc. →