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 |