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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K123317
Device Name EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact SHERI L MUSGNUNG
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact SHERI L MUSGNUNG
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
NWB  
Date Received10/25/2012
Decision Date 12/11/2012
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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