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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 K120791
Device Name AMBIENT TURBOFLASH 90 IFS
Applicant
ARTHOCARE CORPORATION
7000 WEST WILLIAM CANNON DRIVE
BUILDING ONE
AUSTIN,  TX  78735
Applicant Contact CHERYL FREDERICK
Correspondent
ARTHOCARE CORPORATION
7000 WEST WILLIAM CANNON DRIVE
BUILDING ONE
AUSTIN,  TX  78735
Correspondent Contact CHERYL FREDERICK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/15/2012
Decision Date 12/11/2012
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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