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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
Predetermined Change
Control Plan Authorized		 No
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