The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Tricos T.
Device ID | K051722 |
510k Number | K051722 |
Device Name: | TRICOS T |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362 |
Contact | Brian L Bishop |
Correspondent | Brian L Bishop BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2005-06-27 |
Decision Date | 2005-11-18 |
Summary: | summary |