NEWGEL AND NEWGEL PLUS E

Elastomer, Silicone, For Scar Management

NEWMEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Newmedical Technology, Inc. with the FDA for Newgel And Newgel Plus E.

Pre-market Notification Details

• Device ID: K041704
• 510k Number: K041704
• Device Name: NEWGEL AND NEWGEL PLUS E
• Classification: Elastomer, Silicone, For Scar Management
• Applicant: NEWMEDICAL TECHNOLOGY, INC. 3324 COMMERCIAL AVENUE Northbrook, IL 60062
• Contact: Haitham Matloub
• Correspondent: Haitham Matloub; NEWMEDICAL TECHNOLOGY, INC. 3324 COMMERCIAL AVENUE Northbrook, IL 60062
• Product Code: MDA
• CFR Regulation Number: 878.4025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2004-06-23
• Decision Date: 2005-10-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816465020008	K041704	000
00816465020596	K041704	000
00816465020619	K041704	000
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