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

    SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL

    K Number: K982475 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    9
    Review Days
    68

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    Basic Information

    Device Name
    SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
    K Number
    K982475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tissue Technologies, Inc.
    Date Received
    July 16, 1998
    Decision Date
    September 22, 1998
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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    Other Clearances by Tissue Technologies, Inc.

    K Number Device Name
    K002071 SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
    K000849 SOFTFORM FACIAL IMPLANT
    K973462 SOFTFORM FACIAL IMPLANT
    K970804 TRU-PULSE CO2 SURGICAL LASER
    K963683 TRU-PULSE LASER (MODIFIED)
    K962496 SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
    K960481 SOFT TISSUE AUGMENTATION TUBE
    K952049 TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM