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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K120126
Device Name BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
Applicant
Barosense, Inc.
250 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact SHELIA STEVENS, PHD
Correspondent
Barosense, Inc.
250 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact SHELIA STEVENS, PHD
Regulation Number876.1500
Classification Product Code
FED  
Date Received01/17/2012
Decision Date 09/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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