EPISIL
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
CAMURUS AB
The following data is part of a premarket notification filed by Camurus Ab with the FDA for Episil.
Pre-market Notification Details
| Device ID | K101769 |
| 510k Number | K101769 |
| Device Name: | EPISIL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CAMURUS AB 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell CAMURUS AB 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-24 |
| Decision Date | 2011-09-13 |
| Summary: | summary |
Trademark Results [EPISIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPISIL 79068634 3781349 Live/Registered |
Camurus AB 2009-03-26 |
 EPISIL 73560651 1395559 Dead/Cancelled |
ULTRA CARBON CORPORATION 1985-09-30 |
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