OMARC LLC

FDA Device Registration & Listing · Norwood, MA, US · Registration 3004036118

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004036118
FEI Number
3004036118
Entity Name
OMARC LLC
City/State/Country
Norwood, MA, US
Establishment Address
588 Pleasant Street, Suite 2, Norwood, MA 02062, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
NEOGENIX, LLC dba OGENIX (Owner Number: 9053370)
Owner / Operator Contact Address
3401 Enterprise Parkway, SUITE 340, Beachwood, OH 44122, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190742
PMA Number
N/A

All Registered Proprietary Names

EPIFLO EPIFLO-28

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPJ Chamber, Oxygen, Topical, Extremity General, Plastic Surgery Class 2 878.5650 2015-08-20
KPJ Chamber, Oxygen, Topical, Extremity General, Plastic Surgery Class 2 878.5650 2019-12-23

Official Correspondent

Lawrence Cali

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEOGENIX, LLC dba OGENIX
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004036118. Last updated year: 2026. Please use registration number 3004036118 when referencing this establishment in official correspondence.
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