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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K163236
Device Name COOLIEF Cooled Radiofrequency Kit
Applicant
Halyard Health, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Mary Ann B Kinard
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number882.4725
Classification Product Code
GXI  
Date Received11/17/2016
Decision Date 12/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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