The following data is part of a premarket notification filed by Sophysa Sa with the FDA for Sophy Su8 Pressure Adjustable Valve.
| Device ID | K992465 |
| 510k Number | K992465 |
| Device Name: | SOPHY SU8 PRESSURE ADJUSTABLE VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | SOPHYSA SA 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jacqueline Masse |
| Correspondent | Jacqueline Masse SOPHYSA SA 70 WALNUT ST. Wellesley, MA 02481 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-23 |
| Decision Date | 2000-09-21 |
| Summary: | summary |