BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OLYMPUS GYRUS

    Reg #: 3006131984 · FEI: 3006131984 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SEISA MEDICAL INC
    Registration Number
    3006131984
    FEI Number
    3006131984
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9005 Montana Ave
    City
    El Paso
    State
    TX
    ZIP
    79925
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030935

    Owner / Operator

    Firm Name
    SEISA MEDICAL -TEKNI PLEX
    Operator Number
    10023408
    Address
    9005 Montana Ave
    City
    El Paso
    State
    TX
    Postal Code
    79925
    Country
    US
    Correspondent
    Jason Skramsted

    Products

    Device Name Product Code
    System, Abortion, Vacuum HHI
    Curette, Suction, Endometrial (And Accessories) HHK

    Proprietary Names

    OLYMPUS GYRUS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198