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 |