The following data is part of a premarket notification filed by Tecres Spa with the FDA for Cemex Genta, Genta System And Genta System Fast.
| Device ID | K092773 |
| 510k Number | K092773 |
| Device Name: | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST |
| Classification | Bone Cement |
| Applicant | TECRES SPA 7 Trail House Court Rockville, MD 20850 |
| Contact | Christine Brauer |
| Correspondent | Christine Brauer TECRES SPA 7 Trail House Court Rockville, MD 20850 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-09-09 |
| Decision Date | 2009-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855195006494 | K092773 | 000 |
| 00855195006241 | K092773 | 000 |