The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Burr Hole Valve.
| Device ID | K970578 |
| 510k Number | K970578 |
| Device Name: | RADIONICS BURR HOLE VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-14 |
| Decision Date | 1997-06-04 |
| Summary: | summary |