BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Precise Bite™

    Reg #: 3015119628 · FEI: 3015119628 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENPAK LLC
    Registration Number
    3015119628
    FEI Number
    3015119628
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    939 E Pound Dr N
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K933227

    Owner / Operator

    Firm Name
    EnPak LLC
    Operator Number
    10079528
    Address
    939 E Pound Dr N
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Marlene Mulero-Betances

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Precise Bite™

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)