The following data is part of a premarket notification filed by Integra Neurosciences Implants S.a. with the FDA for Modification To Burr Hole Valve And Shunt System.
| Device ID | K040201 |
| 510k Number | K040201 |
| Device Name: | MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA NEUROSCIENCES IMPLANTS S.A. 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady 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 | 2004-01-29 |
| Decision Date | 2004-02-26 |
| Summary: | summary |