BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYNTECH, INT'L INC.

    Reg #: 3005142514 · FEI: 3005142514 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    SYNTECH, INT'L INC.
    Registration Number
    3005142514
    FEI Number
    3005142514
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17171 DAIMLER AVE.
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040485

    Owner / Operator

    Firm Name
    SYNTECH, INT'L INC.
    Operator Number
    2083467
    Address
    17171 DAIMLER AVE., --
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    NICK - HERBERT

    Products

    Device Name Product Code
    Apparatus, Exhaust, Surgical FYD
    Gown, Surgical FYA
    Mask, Surgical FXX

    Proprietary Names

    Tube Set Surgical Gown low profile short lens sterishield wrap around lens sterile sterishield head gear steri-shield face guard short lens sterile low profile wrap around lens sterishield wrap around lens

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device