The following data is part of a premarket notification filed by Neurocare Group with the FDA for Gemini Standard And Mini Valves.
| Device ID | K974708 |
| 510k Number | K974708 |
| Device Name: | GEMINI STANDARD AND MINI VALVES |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | NEUROCARE GROUP 8401 102ND STREET, SUITE 200 P.O. BOX 390 Pleasant Prairie, WI 53158 -0390 |
| Contact | Lori L Hays |
| Correspondent | Lori L Hays NEUROCARE GROUP 8401 102ND STREET, SUITE 200 P.O. BOX 390 Pleasant Prairie, WI 53158 -0390 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-17 |
| Decision Date | 1998-03-10 |
| Summary: | summary |