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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, accessories, narrow band spectrum
510(k) Number K051645
Device Name EVIS EXERA 160A SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
NWB  
Subsequent Product Codes
FDF   FDS  
Date Received06/20/2005
Decision Date 10/13/2005
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
Recalls CDRH Recalls
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