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FDA 510(k) Application Details - K140523
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K140523
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS, MN 55411 US
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Contact
BRIAN SCHMIDT
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Regulation Number
876.1500
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Classification Product Code
FED
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More FDA Info for this Product Code
Date Received
03/04/2014
Decision Date
07/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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