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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 K121014
Model SOLAR GI INCLUDING MPP PLUS
Device Name SOLAR GI
Original Applicant
MEDICAL MEASUREMENT SYSTEMS,B.V.
colosseum 25
enschede,  NL 7521 pv
Original Contact k. ogink somhorst
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/03/2012
Decision Date 08/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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