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FDA 510(k) Application Details - K151801
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K151801
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
BODDINGTONS PLASTICS LTD
WHEELBARROW PARK ESTATE
PATTENDEN LANE, MARDEN
TONBRIDGE TN12 9QL GB
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Contact
PAUL BLACKMORE
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FED
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/02/2015
Decision Date
08/13/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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