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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 K031169
Device Name MOTILITY VISUALIZATION SYSTEM
Applicant
Sierra Scientific Instruments, Inc.
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Applicant Contact SEAN M CURRY
Correspondent
Sierra Scientific Instruments, Inc.
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Correspondent Contact SEAN M CURRY
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/14/2003
Decision Date 12/12/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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