The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Flow Regulating Valve Systems Osv Ii Models And Integra Flow Regulating Valve Low Flow Models.
| Device ID | K140722 |
| 510k Number | K140722 |
| Device Name: | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 22 TERRY AVENUE Burlington, MA 01803 |
| Contact | Janet Kay |
| Correspondent | Janet Kay INTEGRA LIFESCIENCES CORPORATION 22 TERRY AVENUE Burlington, MA 01803 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-21 |
| Decision Date | 2015-01-06 |
| Summary: | summary |