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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 K262621
Device Name Rapid Barostat Bag (RBB) Pump and Catheter System
Applicant
Mui Scientific, Inc.
145 Traders Blvd. E.,
Unit #34
Mississauga,  CA L4Z 3L3
Applicant Contact Fatemeh Rahimi
Correspondent
Mui Scientific, Inc.
145 Traders Blvd. E.,
Unit #34
Mississauga,  CA L4Z 3L3
Correspondent Contact Fatemeh Rahimi
Regulation Number876.1725
Classification Product Code
FFX  
Date Received07/28/2026
Decision Date 09/30/2026
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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