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FDA 510(k) Application Details - K014269
Device Classification Name
System,Electrogastrography(Egg)
More FDA Info for this Device
510(K) Number
K014269
Device Name
System,Electrogastrography(Egg)
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
16-18 TONSBAKKEN
SKOVLUNDE DK-2740 DK
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Contact
TOVE KJAER
Other 510(k) Applications for this Contact
Regulation Number
876.1735
More FDA Info for this Regulation Number
Classification Product Code
MYE
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More FDA Info for this Product Code
Date Received
12/27/2001
Decision Date
11/21/2002
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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