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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K162074
Device Name Werewolf RF20000 Controller, FLOW 50 Wand
Applicant
ARTHROCARE CORPORATION
7000 W. WILLIAM CANNON DRIVE
AUSTIN,  TX  78735
Applicant Contact SHIRLEY HYINK
Correspondent
ARTHROCARE CORPORATION
7000 W. WILLIAM CANNON DRIVE
AUSTIN,  TX  78735
Correspondent Contact SHIRLEY HYINK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/27/2016
Decision Date 08/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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