The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Tricos A Resorbable Bone Substitute.
| Device ID | K081717 |
| 510k Number | K081717 |
| Device Name: | TRICOS A RESORBABLE BONE SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAULKEGAN RD. MPGR-AL Mcgaw Park, IL 60085 -6730 |
| Contact | Valerie Followell |
| Correspondent | Valerie Followell BAXTER HEALTHCARE CORP. 1620 WAULKEGAN RD. MPGR-AL Mcgaw Park, IL 60085 -6730 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-18 |
| Decision Date | 2008-10-10 |
| Summary: | summary |