The following data is part of a premarket notification filed by Theratronics, Inc. with the FDA for Theraplan Plus Version 1.2.
| Device ID | K970236 |
| 510k Number | K970236 |
| Device Name: | THERAPLAN PLUS VERSION 1.2 |
| Classification | Accelerator, Linear, Medical |
| Applicant | THERATRONICS, INC. 413 MARCH ROAD P.O. BOX 13140 Kanata Ontario, CA K2k 2b7 |
| Contact | E.s. Martell |
| Correspondent | E.s. Martell THERATRONICS, INC. 413 MARCH ROAD P.O. BOX 13140 Kanata Ontario, CA K2k 2b7 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-07-09 |
| Summary: | summary |