The following data is part of a premarket notification filed by Enzysurge, Ltd. with the FDA for Dermastream.
| Device ID | K060046 |
| 510k Number | K060046 |
| Device Name: | DERMASTREAM |
| Classification | Dressing, Wound, Occlusive |
| Applicant | ENZYSURGE, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub ENZYSURGE, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | NAD |
| CFR Regulation Number | 878.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-06 |
| Decision Date | 2006-02-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DERMASTREAM 78856459 3431222 Live/Registered |
EnzySurge Ltd. 2006-04-07 |