The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Contour Flex Plus Valve.
| Device ID | K964386 |
| 510k Number | K964386 |
| Device Name: | RADIONICS CONTOUR FLEX PLUS VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Michael Arnold, Ph.d. |
| Correspondent | Michael Arnold, Ph.d. 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 | 1996-11-04 |
| Decision Date | 1997-01-31 |
| Summary: | summary |