The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Equi-flow Valve, Ventricular And Peritoneal Catheter With Ez-coat.
| Device ID | K980903 |
| 510k Number | K980903 |
| Device Name: | RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Michael A Arnold, Ph.d |
| Correspondent | Michael A 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 | 1998-03-10 |
| Decision Date | 1999-04-19 |
| Summary: | summary |