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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K120357
Device Name ENDOSCOPE REPROCESSOR OER-MINI
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
FEB  
Date Received02/06/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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