Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005369309

FEI Number

3005369309

Entity Name

NEWMEDICAL TECHNOLOGY, INC.

City/State/Country

NORTHBROOK, IL, US

Establishment Address

4065 Commercial Avenue, NORTHBROOK, IL 60062, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEWMEDICAL TECHNOLOGY, INC. (Owner Number: 9064417)

Owner / Operator Contact Address

4065 Commercial Avenue, --, Northbrook, IL 60062, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121361

PMA Number

N/A

All Registered Proprietary Names

Silagen Silicone Gel for Scar Management NewGel+E Silicone Gel Ointment for Scar Management Silagen Silicone Gel for Scars +SPF30 NewGel+UV Silicone Gel for Scars +SPF30 MYNEWGEL Silagen Acne Scar + Spot Corrector NXGEL Silicone Gel for Scar Management NewGel+ Silicone Sheeting Silagen Silicone Sheeting NXGEL Silicone Sheeting DevraSorb Polyurethane Foam AWC Dressing LIPOLOCK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2012-04-13
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2007-08-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-12-06

Official Correspondent

A. MICHAEL HANNA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEWMEDICAL TECHNOLOGY, INC.

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

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

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3009192857	Neodyne Biosciences, Inc.	Fremont, CA, US
3005857283	PRECO, LLC	Somerset, WI, US
3019769561	ScarPro NV	Aalter Flanders, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005369309. Last updated year: 2026. Please use registration number 3005369309 when referencing this establishment in official correspondence.