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 |