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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K092729
Device Name BAXANO NEURO CHECK DEVICE
Applicant
Baxano, Inc.
1171 Barroilhet Ave.
Hillsborough,  CA  94010 -6577
Applicant Contact CINDY DOMECUS
Correspondent
Baxano, Inc.
1171 Barroilhet Ave.
Hillsborough,  CA  94010 -6577
Correspondent Contact CINDY DOMECUS
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/04/2009
Decision Date 10/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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