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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 K950974
Device Name KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS
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 Received03/02/1995
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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