The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Mini & Standard Shunt Valve.
| Device ID | K843132 |
| 510k Number | K843132 |
| Device Name: | RADIONICS MINI & STANDARD SHUNT VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | RADIONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-09 |
| Decision Date | 1984-09-12 |