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FDA 510(k) Application Details - K153588
Device Classification Name
Pump, Air, Non-Manual, For Endoscope
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510(K) Number
K153588
Device Name
Pump, Air, Non-Manual, For Endoscope
Applicant
ENDOCHOICE, INC.
11810 WILLS RD.
ALPHARETTA, GA 30009 US
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Contact
Daniel Hoefer
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FEQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2015
Decision Date
02/24/2016
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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