The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Tricos A Resorbable Substitute.
| Device ID | K081721 |
| 510k Number | K081721 |
| Device Name: | TRICOS A RESORBABLE SUBSTITUTE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Barbara K Barbeau |
| Correspondent | Barbara K Barbeau BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-06-18 |
| Decision Date | 2008-08-06 |
| Summary: | summary |