The following data is part of a premarket notification filed by Tcm Associates Ltd with the FDA for Granostm - Beta Tricalcium Phosphate Synthetic Bone Granules.
| Device ID | K143692 |
| 510k Number | K143692 |
| Device Name: | GranOSTM - Beta Tricalcium Phosphate Synthetic Bone Granules |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | TCM ASSOCIATES LTD 3, HILLGROVE BUSINESS PARK NASEING ROAD Naseing Essex, GB En9 2hb |
| Contact | Iain Alligan |
| Correspondent | Iain Alligan TCM ASSOCIATES LTD 3, HILLGROVE BUSINESS PARK NASEING ROAD Naseing Essex, GB En9 2hb |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-08-21 |
| Summary: | summary |