The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Ps Medical Strata Nsc Lumboperitoneal Valve And Shunt System.
| Device ID | K091312 |
| 510k Number | K091312 |
| Device Name: | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffery Henderson |
| Correspondent | Jeffery Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2009-09-02 |
| Summary: | summary |