BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide

    Reg #: 3003990090 · FEI: 3003990090 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CALDERA MEDICAL, INC.
    Registration Number
    3003990090
    FEI Number
    3003990090
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4360 Park Terrace Drive
    City
    Westlake Village
    State
    CA
    ZIP
    91361
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181151

    Owner / Operator

    Firm Name
    Caldera Medical
    Operator Number
    10028052
    Address
    4360 Park Terrace Drive
    City
    Westlake Village
    State
    CA
    Postal Code
    91361
    Country
    US
    Correspondent
    Vicki Gail

    Products

    Device Name Product Code
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ

    Proprietary Names

    GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility