Coolief Radiofrequency Generator (CRG) System

Generator, Lesion, Radiofrequency

Avanos Medical, Inc.

The following data is part of a premarket notification filed by Avanos Medical, Inc. with the FDA for Coolief Radiofrequency Generator (crg) System.

Pre-market Notification Details

Device IDK192491
510k NumberK192491
Device Name:Coolief Radiofrequency Generator (CRG) System
ClassificationGenerator, Lesion, Radiofrequency
Applicant Avanos Medical, Inc. 5405 Windward Parkway, Suite 100 Alpharetta,  GA  30004
ContactThomas Kozma
CorrespondentThomas Kozma
Avanos Medical, Inc. 5405 Windward Parkway, Suite 100 Alpharetta,  GA  30004
Product CodeGXD  
CFR Regulation Number882.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-11
Decision Date2020-02-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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