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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urethroscope
510(k) Number K091600
Device Name DIRECTVISION GUIDE SYSTEM
Applicant
PERCUVISION LLC
765 NORTH HAMILTON RD.
SUITE 260A
GAHANNA,  OH  43230
Applicant Contact ERROL O SINGH, M.D.
Correspondent
PERCUVISION LLC
765 NORTH HAMILTON RD.
SUITE 260A
GAHANNA,  OH  43230
Correspondent Contact ERROL O SINGH, M.D.
Regulation Number876.1500
Classification Product Code
FGC  
Date Received06/03/2009
Decision Date 08/25/2009
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
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