The following data is part of a premarket notification filed by Integra Neurosciences Implants S.a. with the FDA for Contour-flex Valve And Shunt System.
| Device ID | K033698 |
| 510k Number | K033698 |
| Device Name: | CONTOUR-FLEX 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 | 2003-11-25 |
| Decision Date | 2003-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780032885 | K033698 | 000 |
| 00382830055659 | K033698 | 000 |
| 00382830055680 | K033698 | 000 |
| 00382830055758 | K033698 | 000 |
| 00382830055833 | K033698 | 000 |
| 00382830055895 | K033698 | 000 |
| 00382830055901 | K033698 | 000 |
| 00382830055987 | K033698 | 000 |
| 00382830055994 | K033698 | 000 |
| 00382830056007 | K033698 | 000 |
| 00382830056045 | K033698 | 000 |
| 00382830056083 | K033698 | 000 |
| 00382830056090 | K033698 | 000 |
| 00382830056106 | K033698 | 000 |
| 00382830056113 | K033698 | 000 |
| 00382830056120 | K033698 | 000 |
| 10381780032861 | K033698 | 000 |
| 10381780032878 | K033698 | 000 |
| 10381780035664 | K033698 | 000 |