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 |