BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OTK 210 One Tray Processing Kit

    Reg #: 3021119558 · FEI: 3021119558 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Assembly-Tek LLC
    Registration Number
    3021119558
    FEI Number
    3021119558
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    295 S Alex Rd
    City
    Dayton
    State
    OH
    ZIP
    45449
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052567

    Owner / Operator

    Firm Name
    Assembly-Tek LLC
    Operator Number
    10083684
    Address
    295 S. Alex
    City
    West Carrollton
    State
    OH
    Postal Code
    45449
    Country
    US

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    OTK 210 One Tray Processing Kit

    Establishment Types

    Repack or Relabel Medical Device