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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 K081742
Device Name BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
Applicant
BAXANO, INC.
2660 MARINE WAY, SUITE B
MOUNTAIN VIEW,  CA  94043
Applicant Contact TRENA DEPEL
Correspondent
BAXANO, INC.
2660 MARINE WAY, SUITE B
MOUNTAIN VIEW,  CA  94043
Correspondent Contact TRENA DEPEL
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Code
HAE  
Date Received06/19/2008
Decision Date 09/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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