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 |