The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for External Csf Drainage Management Systems.
| Device ID | K972994 |
| 510k Number | K972994 |
| Device Name: | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Contact | Lori L Hays |
| Correspondent | Lori L Hays INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-12 |
| Decision Date | 1997-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780072393 | K972994 | 000 |
| 10381780072164 | K972994 | 000 |
| 10381780071990 | K972994 | 000 |
| 10381780071709 | K972994 | 000 |
| 10381780071693 | K972994 | 000 |
| 30381780071666 | K972994 | 000 |
| 10381780071648 | K972994 | 000 |
| 10381780071099 | K972994 | 000 |
| 10381780542193 | K972994 | 000 |