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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ureteroscope and accessories, flexible/rigid
510(k) Number K033651
Device Name OLYMPUS VIDEO URETEROSCOPE, NTSC
Applicant
OLYMPUS WINTER & IBE GMBH
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact TINA STEFFANIE-OAK
Correspondent
OLYMPUS WINTER & IBE GMBH
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number876.1500
Classification Product Code
FGB  
Date Received11/20/2003
Decision Date 01/30/2004
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
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