The following data is part of a premarket notification filed by Sophysa Sa with the FDA for Polaris Pressure Adjustable Valve, Models Spv, Spva, Spvb, Spv-140, Spv-300, Spv-400.
| Device ID | K090342 |
| 510k Number | K090342 |
| Device Name: | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | SOPHYSA SA 2884 DANAPOPLAR Dana Point, CA 92629 |
| Contact | Esther Saltz |
| Correspondent | Esther Saltz SOPHYSA SA 2884 DANAPOPLAR Dana Point, CA 92629 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-10 |
| Decision Date | 2009-08-11 |
| Summary: | summary |