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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 K100584
Device Name EVIS EXERAII 180 SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
REGULATORY AFFAIRS & QUALITY
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Applicant Contact STACY A KLUESNER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
REGULATORY AFFAIRS & QUALITY
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact STACY A KLUESNER
Regulation Number876.1500
Classification Product Code
NWB  
Subsequent Product Codes
FDF   FDS  
Date Received03/02/2010
Decision Date 07/02/2010
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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