The following data is part of a premarket notification filed by Sophysa Sa with the FDA for Siphonx Gravitational Antisiphon Device.
| Device ID | K091328 |
| 510k Number | K091328 |
| Device Name: | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | SOPHYSA SA 8502 E. CHAPMAN AVE SUITE 234 Orange, CA 92869 |
| Contact | Gustavo Kobrin |
| Correspondent | Gustavo Kobrin SOPHYSA SA 8502 E. CHAPMAN AVE SUITE 234 Orange, CA 92869 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-05 |
| Decision Date | 2010-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760124131697 | K091328 | 000 |