BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TEMPORARY PACING PRODUCTS

    Reg #: 1035166 · FEI: 1035166 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSCOR INC.
    Registration Number
    1035166
    FEI Number
    1035166
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4875 Palm Harbor Blvd
    City
    PALM HARBOR
    State
    FL
    ZIP
    34683
    Country
    US

    Regulatory Submissions

    510(k) Number
    K861403

    Owner / Operator

    Firm Name
    OSCOR INC.
    Operator Number
    1035166
    Address
    4875 Palm Harbor Blvd, --
    City
    Palm Harbor
    State
    FL
    Postal Code
    34683
    Country
    US
    Correspondent
    Ronnie - Greco

    Products

    Device Name Product Code
    Electrode, Pacemaker, Temporary LDF

    Proprietary Names

    TEMPORARY PACING PRODUCTS ELECTRODE, PACEMAKER, TEMPORARY TB

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device