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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K102594
Device Name IO-FLEX CATHETER
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 Number868.5120
Classification Product Code
BSO  
Date Received09/09/2010
Decision Date 01/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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