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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 K140521
Device Name TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH
Applicant
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Applicant Contact MITCHELL A DHORITY
Correspondent
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Correspondent Contact MITCHELL A DHORITY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/04/2014
Decision Date 06/10/2014
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
Predetermined Change
Control Plan Authorized		 No
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