The following data is part of a premarket notification filed by Abbott Medical with the FDA for Abbott Medical Grounding Pad, Model Rf-dgp-is.
| Device ID | K203293 |
| 510k Number | K203293 |
| Device Name: | Abbott Medical Grounding Pad, Model RF-DGP-IS |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | Abbott Medical 5050 Nathan Lane Plymouth, MN 55442 |
| Contact | Jordan Hanson |
| Correspondent | Jordan Hanson Abbott Medical 5050 Nathan Lane Plymouth, MN 55442 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-09 |
| Decision Date | 2022-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067034516 | K203293 | 000 |
| 05415067049650 | K203293 | 000 |