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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 K153588
Device Name EndoChoice Water Bottle Cap System
Applicant
Endochoice, Inc.
11810 Wills Rd.
Alpharetta,  GA  30009
Applicant Contact Daniel Hoefer
Correspondent
Endochoice, Inc.
11810 Wills Rd.
Alpharetta,  GA  30009
Correspondent Contact Daniel Hoefer
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received12/16/2015
Decision Date 02/24/2016
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
Predetermined Change
Control Plan Authorized		 No
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