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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 K160044
FOIA Releasable 510(k) K160044
Device Name Image1 SPIES System
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact SUSIE S. CHEN
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact WINKIE WONG
Regulation Number876.1500
Classification Product Code
FET  
Date Received01/08/2016
Decision Date 02/01/2016
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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