The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionics Single Use Ground Pad (dgp-hp).
| Device ID | K030697 |
| 510k Number | K030697 |
| Device Name: | RADIONICS SINGLE USE GROUND PAD (DGP-HP) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-06 |
| Decision Date | 2003-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524001293 | K030697 | 000 |