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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
Device Name SOLAR GI
Original Applicant
colosseum 25
enschede,  NL 7521 pv
Original Contact k. ogink somhorst
Regulation Number876.1725
Classification Product Code
Date Received04/03/2012
Decision Date 08/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No