BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LT-300 HD

    Reg #: 3036423383 · FEI: 3036423383 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Lutech Industries
    Registration Number
    3036423383
    FEI Number
    3036423383
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3910 Industrial Blvd
    City
    Indianapolis
    State
    IN
    ZIP
    46254
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160380

    Owner / Operator

    Firm Name
    Waverly Life Sciences LLC
    Operator Number
    10092757
    Address
    7515 Pelican Bay Blvd 10A
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US
    Correspondent
    Theodore Schenberg

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    LT-300 HD

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device