Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K192491
Device Name Coolief Radiofrequency Generator (CRG) System
Applicant
Avanos Medical, Inc.
5405 Windward Parkway, Suite 100
Alpharetta,  GA  30004
Applicant Contact Thomas Kozma
Correspondent
Avanos Medical, Inc.
5405 Windward Parkway, Suite 100
Alpharetta,  GA  30004
Correspondent Contact Thomas Kozma
Regulation Number882.4400
Classification Product Code
GXD  
Subsequent Product Code
GXI  
Date Received09/11/2019
Decision Date 02/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-