The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Synergist Power Pack.
| Device ID | K960414 |
| 510k Number | K960414 |
| Device Name: | SYNERGIST POWER PACK |
| Classification | Unit, Phacofragmentation |
| Applicant | CHIRON VISION CORP. 555 W. ARROW HWY. Claremont, CA 91711 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon CHIRON VISION CORP. 555 W. ARROW HWY. Claremont, CA 91711 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-04-24 |
| Summary: | summary |