The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Osv Ii Low Flow Low Pro Valve.
| Device ID | K093968 |
| 510k Number | K093968 |
| Device Name: | OSV II LOW FLOW LOW PRO VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Donna Millisky |
| Correspondent | Donna Millisky INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. 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 | 2009-12-23 |
| Decision Date | 2010-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2729OS512P1 | K093968 | 000 |
| M2729OS502P1 | K093968 | 000 |
| M272909512P1 | K093968 | 000 |
| M272909500P1 | K093968 | 000 |