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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 K071094
Device Name MODIFICATION TO SOLAR GI
Applicant
MEDICAL MEASUREMENT SYSTEMS,B.V.
COLOSSEUM 25
ENSCHEDE,  NL 7521 PV
Applicant Contact KARIN OGINK-SOMHORST
Correspondent
MEDICAL MEASUREMENT SYSTEMS,B.V.
COLOSSEUM 25
ENSCHEDE,  NL 7521 PV
Correspondent Contact KARIN OGINK-SOMHORST
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/18/2007
Decision Date 08/13/2007
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
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