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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
Model ASHA6001.01
Device Name AMBIENT TURBOFLASH 90 IFS
Original Applicant
ARTHOCARE CORPORATION
7000 west william cannon drive
building one
austin,  TX  78735
Original Contact cheryl frederick
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/15/2012
Decision Date 12/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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