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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 K113073
Device Name IO-TOME DEVICE
Applicant
BAXANO, INC.
655 RIVER OAKS PKWY
SAN JOSE,  CA  95134
Applicant Contact EDWARD J SINCLAIR
Correspondent
BAXANO, INC.
655 RIVER OAKS PKWY
SAN JOSE,  CA  95134
Correspondent Contact EDWARD J SINCLAIR
Regulation Number882.4840
Classification Product Code
HAE  
Date Received10/17/2011
Decision Date 07/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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