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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 K161482
Device Name EndoChoice Water Bottle Cap Irrigation System
Applicant
ENDOCHOICE, INC.
11810 WILLS RD.
ALPHARETTA,  GA  30009
Applicant Contact DAINEL HOEFER
Correspondent
ENDOCHOICE, INC.
11810 WILLS RD.
ALPHARETTA,  GA  30009
Correspondent Contact DANIEL HOEFER
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received05/31/2016
Decision Date 06/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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