BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS

    K Number: K913043 · Decision Aug 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    35
    Review Days
    64

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    Basic Information

    Device Name
    MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
    K Number
    K913043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tecnol New Jersey Wound Care, Inc.
    Date Received
    June 20, 1991
    Decision Date
    August 23, 1991
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    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
    FXX Mask, Surgical

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    Other Clearances by Tecnol New Jersey Wound Care, Inc.

    K Number Device Name
    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
    K882641 TECNOL CATHETER LEG STRAP
    Search all 35 clearances from Tecnol New Jersey Wound Care, Inc. →