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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 K003325
Device Name KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
Applicant
Karl Storz Imaging, Inc.
175 Cremona Dr.
Goleta,  CA  93117
Applicant Contact TERRY FERNANDEZ
Correspondent
Karl Storz Imaging, Inc.
175 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact TERRY FERNANDEZ
Regulation Number876.1500
Classification Product Code
FET  
Date Received10/24/2000
Decision Date 04/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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