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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K120524
Device Name SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
Original Applicant
MUI SCIENTIFIC
145 traders blvd. east
unit 33-34
mississauga,  CA l4z 3l3
Original Contact tammy mui
Regulation Number876.1725
Classification Product Code
FFX  
Date Received02/22/2012
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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