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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K180414
Device Name EPX-4440FN Digital Video Processor with Light Source
Applicant
Fujifilm New Development U.S.A., Inc.
318 Bear Hill Rd.
Waltham,  MA  02451
Applicant Contact Stephen Mariano
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Codes
GCT   PEA  
Date Received02/15/2018
Decision Date 05/24/2018
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
Predetermined Change
Control Plan Authorized		 No
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