The following data is part of a premarket notification filed by Integra Neurosciences Implants S.a. with the FDA for Osv Ii.
| Device ID | K081773 |
| 510k Number | K081773 |
| Device Name: | OSV II |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA NEUROSCIENCES IMPLANTS S.A. 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta INTEGRA NEUROSCIENCES IMPLANTS S.A. 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-23 |
| Decision Date | 2008-11-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OSV II 76314101 2653979 Live/Registered |
INTEGRA NEUROSCIENCES IMPLANTS S.A. 2001-09-19 |