Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006802076

FEI Number

3006802076

Entity Name

FOCUS HEALTH GROUP

City/State/Country

Knoxville, TN, US

Establishment Address

5802 Kingston Pike, Knoxville, TN 37919, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Focus Health Group (Owner Number: 10060699)

Owner / Operator Contact Address

5802 Kingston Pike, Knoxville, TN 37919, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211123

PMA Number

N/A

All Registered Proprietary Names

ZeniFoam-AG Gentle ZeniFIBER AG ZeniCol Particles 1gram ZeniCol ZeniCol Collagen Particles Sub Occipital Bandage ZeniFoam-Ag ZeniCol Collagen Dressing ZeniFiber ZeniAbsorb ZeniABSORB Border Plus Epinephrine Professional ZeniGAUZE Gentle Border ZeniCol AG ZeniFoam-Ag Gentle Border ZeniFoam Gentle Border AG ZENIGEL-AG Silver Amorphous Wound Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-04-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-04-27
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-12-17
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-12-17
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-12-16
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2019-08-21
PPA	Bladder Irrigation Kit	Gastroenterology, Urology	Class 2	876.5130	2019-08-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-12-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-12-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2019-08-21
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2019-07-10
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2024-12-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-04-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-04-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-05-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-04-10

Official Correspondent

Elizabeth Wilson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Focus Health Group

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006802076. Last updated year: 2026. Please use registration number 3006802076 when referencing this establishment in official correspondence.