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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K113120
Device Name CHF-Y0005
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact SHERI MUSGNUNG
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact SHERI MUSGNUNG
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Code
NWB  
Date Received10/21/2011
Decision Date 09/25/2012
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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