The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Model Rfg-3c Radiofrequency Lesion Generator.
| Device ID | K901540 |
| 510k Number | K901540 |
| Device Name: | MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | William J Rittman |
| Correspondent | William J Rittman RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-02 |
| Decision Date | 1991-04-08 |