The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Tricos T Resorbable Bone Substitute.
Device ID | K073571 |
510k Number | K073571 |
Device Name: | TRICOS T RESORBABLE BONE SUBSTITUTE |
Classification | Bone Grafting Material, Synthetic |
Applicant | BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN ROAD MPGR-AL Mcgaw Park, IL 60085 |
Contact | Barbara K Barbeau |
Correspondent | Barbara K Barbeau BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN ROAD MPGR-AL Mcgaw Park, IL 60085 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2007-12-20 |
Decision Date | 2008-04-08 |
Summary: | summary |