The following data is part of a premarket notification filed by Avanos Medical, Inc. with the FDA for Coolief Radiofrequency Generator (crg) System.
| Device ID | K192491 |
| 510k Number | K192491 |
| Device Name: | Coolief Radiofrequency Generator (CRG) System |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | Avanos Medical, Inc. 5405 Windward Parkway, Suite 100 Alpharetta, GA 30004 |
| Contact | Thomas Kozma |
| Correspondent | Thomas Kozma Avanos Medical, Inc. 5405 Windward Parkway, Suite 100 Alpharetta, GA 30004 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-11 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193493473090 | K192491 | 000 |
| 00193493000357 | K192491 | 000 |
| 00193493000692 | K192491 | 000 |
| 00193493473052 | K192491 | 000 |
| 00193493473069 | K192491 | 000 |
| 00193493473076 | K192491 | 000 |
| 00193493475018 | K192491 | 000 |
| 00193493000401 | K192491 | 000 |
| 00193493000418 | K192491 | 000 |
| 00193493473021 | K192491 | 000 |
| 00193493473038 | K192491 | 000 |
| 00193493473014 | K192491 | 000 |
| 00193493000340 | K192491 | 000 |