The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Osv Ii Lumbar Valve System And Osv Ii Low Flow Lumbar Valve System.
| Device ID | K092395 |
| 510k Number | K092395 |
| Device Name: | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Donna Millisky |
| Correspondent | Donna Millisky INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780034025 | K092395 | 000 |
| 10381780034018 | K092395 | 000 |
| 10381780033837 | K092395 | 000 |
| 10381780033820 | K092395 | 000 |