The following data is part of a premarket notification filed by Tissue Repair Company with the FDA for Excellagen.
| Device ID | K110318 |
| 510k Number | K110318 |
| Device Name: | EXCELLAGEN |
| Classification | Dressing, Wound, Collagen |
| Applicant | TISSUE REPAIR COMPANY 12255 EL CAMINO REAL SUITE 250 San Diego, CA 92130 |
| Contact | Lois Chandler |
| Correspondent | Lois Chandler TISSUE REPAIR COMPANY 12255 EL CAMINO REAL SUITE 250 San Diego, CA 92130 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-02 |
| Decision Date | 2011-10-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EXCELLAGEN 88433317 5920429 Live/Registered |
Olaregen Therapeutix Inc. 2019-05-16 |
![]() EXCELLAGEN 77848064 4168303 Dead/Cancelled |
Tissue Repair Company 2009-10-14 |