The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Rfg-dgp Disposable Grounding Pads.
| Device ID | K923647 |
| 510k Number | K923647 |
| Device Name: | RFG-DGP DISPOSABLE GROUNDING PADS |
| Classification | Electrode, Gel, Electrosurgical |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | JOT |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1992-11-09 |