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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 K122294
Device Name PRESSURIZED INFUSION PUMP
Applicant
MUI SCIENTIFIC
145 TRADERS BLVD. EAST, # 34
MISSISSAUGA,  CA L4Z 3L3
Applicant Contact TAMMY MUI
Correspondent
MUI SCIENTIFIC
145 TRADERS BLVD. EAST, # 34
MISSISSAUGA,  CA L4Z 3L3
Correspondent Contact TAMMY MUI
Regulation Number876.1725
Classification Product Code
FFX  
Date Received07/31/2012
Decision Date 11/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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