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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
Applicant
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Applicant Contact K. OGINK SOMHORST
Correspondent
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Correspondent Contact K. OGINK SOMHORST
Regulation Number876.1725
Classification Product Code
FFX  
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
Predetermined Change
Control Plan Authorized		 No
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