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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 K823701
Device Name MOTILITY CATHETERS
Applicant
Mui Scientific
2570 Haines Rd., Unit #1
Mississauga, Ontario,  CA L4Y 4A3
Correspondent
Mui Scientific
2570 Haines Rd., Unit #1
Mississauga, Ontario,  CA L4Y 4A3
Regulation Number876.1725
Classification Product Code
FFX  
Date Received12/08/1982
Decision Date 02/15/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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