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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 K192027
Device Name WEREWOLF COBLATION System, COBLATION HALO Wand
Applicant
Arthrocare Corporation
7000 West William Cannon Drive
Austin,  TX  78735
Applicant Contact Shruthi Bhat
Correspondent
Arthrocare Corporation
7000 West William Cannon Drive
Austin,  TX  78735
Correspondent Contact Shruthi Bhat
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/29/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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