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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rongeur, manual
510(k) Number K113533
Device Name NEURO CHECK DEVICE WITH IO-FLEX WIRE
Original Applicant
BAXANO, INC.
655 river oaks pkwy
san jose,  CA  95134
Original Contact edward sinclair
Regulation Number882.4840
Classification Product Code
HAE  
Date Received11/30/2011
Decision Date 04/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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