The following data is part of a premarket notification filed by Radionics, A Division Of Tyco Healthcare Group Lp with the FDA for Radionics Varilink 2.
| Device ID | K023519 |
| 510k Number | K023519 |
| Device Name: | RADIONICS VARILINK 2 |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-21 |
| Decision Date | 2003-01-16 |
| Summary: | summary |