The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Conformax Mmlc Vr1.
| Device ID | K993594 |
| 510k Number | K993594 |
| Device Name: | CONFORMAX MMLC VR1 |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Nancy Macdonald |
| Correspondent | Nancy Macdonald RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-25 |
| Decision Date | 1999-12-15 |
| Summary: | summary |