BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OMARC LLC

    Reg #: 3004036118 · FEI: 3004036118 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

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    Registration Details

    Registration Name
    OMARC LLC
    Registration Number
    3004036118
    FEI Number
    3004036118
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    588 Pleasant Street, Suite 2
    City
    Norwood
    State
    MA
    ZIP
    02062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120764

    Owner / Operator

    Firm Name
    NEOGENIX, LLC dba OGENIX
    Operator Number
    9053370
    Address
    3401 Enterprise Parkway, SUITE 340
    City
    Beachwood
    State
    OH
    Postal Code
    44122
    Country
    US
    Correspondent
    Lawrence J Cali

    Products

    Device Name Product Code
    Chamber, Oxygen, Topical, Extremity KPJ

    Proprietary Names

    EPIFLO EPIFLO-28

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198