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FDA 510(k) Application Details - K011472
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
510(K) Number
K011472
Device Name
System, Gastrointestinal Motility (Electrical)
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
16-18 TONSBAKKEN
SKOVLUNDE DK-2740 DK
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Contact
TOVE KJAER
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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
05/14/2001
Decision Date
08/10/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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