The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Monitorr Icp External Drainage And Monitoring Systems.
| Device ID | K062599 |
| 510k Number | K062599 |
| Device Name: | MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08540 |
| Contact | Darlene M Welsh |
| Correspondent | Darlene M Welsh INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08540 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780112266 | K062599 | 000 |
| 10381780112167 | K062599 | 000 |
| 10381780112174 | K062599 | 000 |
| 10381780112181 | K062599 | 000 |
| 10381780112198 | K062599 | 000 |
| 10381780112204 | K062599 | 000 |
| 10381780112211 | K062599 | 000 |
| 10381780112228 | K062599 | 000 |
| 10381780112242 | K062599 | 000 |
| 10381780112259 | K062599 | 000 |
| 10381780112143 | K062599 | 000 |