The following data is part of a premarket notification filed by Integra Neurosciences Implants S.a. with the FDA for Low Flow Osv Ii Hydrocephalus Valve.
| Device ID | K042192 |
| 510k Number | K042192 |
| Device Name: | LOW FLOW OSV II HYDROCEPHALUS VALVE |
| 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 | 2004-08-12 |
| Decision Date | 2004-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780036050 | K042192 | 000 |
| 10381780033844 | K042192 | 000 |
| 10381780033813 | K042192 | 000 |
| 10381780033806 | K042192 | 000 |
| 10381780033790 | K042192 | 000 |
| 10381780033783 | K042192 | 000 |
| 10381780033776 | K042192 | 000 |
| 10381780033769 | K042192 | 000 |
| 10381780033752 | K042192 | 000 |
| 10381780033745 | K042192 | 000 |
| 10381780033851 | K042192 | 000 |
| 10381780033868 | K042192 | 000 |
| 10381780033875 | K042192 | 000 |
| 10381780036043 | K042192 | 000 |
| 10381780036029 | K042192 | 000 |
| 10381780036005 | K042192 | 000 |
| 10381780035435 | K042192 | 000 |
| 10381780035428 | K042192 | 000 |
| 10381780033912 | K042192 | 000 |
| 10381780033905 | K042192 | 000 |
| 10381780033899 | K042192 | 000 |
| 10381780033882 | K042192 | 000 |
| 10381780033738 | K042192 | 000 |