FDA 510(k) Application Details - K031084

Device Classification Name System, Gastrointestinal Motility (Electrical)

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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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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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