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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 K230914
Device Name ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)
Applicant
Arthrocare Corporation
7000 West William Cannon Drive
Austin,  TX  78735
Applicant Contact Pragnya Bakka
Correspondent
Arthrocare Corporation
7000 West William Cannon Drive
Austin,  TX  78735
Correspondent Contact Pragnya Bakka
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/31/2023
Decision Date 06/26/2023
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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