The following data is part of a premarket notification filed by Benvenue Medical, Inc. with the FDA for Benvenue Vcf Osteo Coil System.
| Device ID | K070293 |
| 510k Number | K070293 |
| Device Name: | BENVENUE VCF OSTEO COIL SYSTEM |
| Classification | Spinal Channeling Instrument, Vertebroplasty |
| Applicant | BENVENUE MEDICAL, INC. 1235 PEAR AVENUE, #111 Mountain View, CA 94043 |
| Contact | Laurent Schaller |
| Correspondent | Laurent Schaller BENVENUE MEDICAL, INC. 1235 PEAR AVENUE, #111 Mountain View, CA 94043 |
| Product Code | OCJ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-31 |
| Decision Date | 2007-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813478020193 | K070293 | 000 |
| 00815212023477 | K070293 | 000 |
| 00815212023637 | K070293 | 000 |
| 00815212023620 | K070293 | 000 |
| 00815212023583 | K070293 | 000 |
| 00815212023644 | K070293 | 000 |
| 00813478020063 | K070293 | 000 |
| 00813478020070 | K070293 | 000 |
| 00813478020186 | K070293 | 000 |
| 00815212023613 | K070293 | 000 |