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 |