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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
Applicant
BAXANO, INC.
655 RIVER OAKS PKWY
SAN JOSE,  CA  95134
Applicant Contact EDWARD SINCLAIR
Correspondent
BAXANO, INC.
655 RIVER OAKS PKWY
SAN JOSE,  CA  95134
Correspondent 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 Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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