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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K160725
Device Name EndoFLIP
Applicant
CROSPON LTD.
GALWAY BUSINESS PARK, DANGAN
GALWAY,  IE
Applicant Contact JOHN O'DEA
Correspondent
CROSPON LTD.
GALWAY BUSINESS PARK, DANGAN
GALWAY,  IE
Correspondent Contact PAUL DRYDEN
Regulation Number876.1725
Classification Product Code
FFX  
Date Received03/16/2016
Decision Date 05/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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