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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K040949
Device Name VIADUCT MINISCOPE AND ACCESSORIES
Applicant
ACUEITY, INC.
100 HAMILTON AVE., SUITE 140
PALO ALTO,  CA  94301
Applicant Contact NANCY LINCE
Correspondent
KEMA QUALITY B.V.
P.O. BOX 5185
6802 ED ARNHEM
ARNHEM,  NL
Correspondent Contact J.A. VAN VUGT
Regulation Number876.1500
Classification Product Code
GCT  
Date Received04/12/2004
Decision Date 05/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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