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