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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Motility System, Capsule
510(k) Number K092342
Device Name SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
Applicant
The Smartpill Corporation
847 Main St.
Buffalo,  NY  14203 -1109
Applicant Contact KATHLEEN SELOVER
Correspondent
The Smartpill Corporation
847 Main St.
Buffalo,  NY  14203 -1109
Correspondent Contact KATHLEEN SELOVER
Regulation Number876.1725
Classification Product Code
NYV  
Date Received08/04/2009
Decision Date 10/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00603707
NCT00857363
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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