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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, air, non-manual, for endoscope
510(k) Number K112576
Device Name ENDOCHOICE WATER BOTTLE CAP SYSTEM
Original Applicant
ENDOCHOICE, INC.
11810 wills road
suite 100
alpharetta,  GA  30009
Original Contact theron gober
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received09/06/2011
Decision Date 01/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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