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FDA 510(k) Application Details - K031084
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
510(K) Number
K031084
Device Name
System, Gastrointestinal Motility (Electrical)
Applicant
MEDICAL MEASUREMENT SYSTEMS,B.V.
COLOSSEUM 25
ENSCHEDE 7521 PV NL
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Contact
KARIN OGINK-SOMHORST
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Regulation Number
876.1725
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Classification Product Code
FFX
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More FDA Info for this Product Code
Date Received
04/04/2003
Decision Date
03/19/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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