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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K083155
Device Name HD CAMERA HEAD OTV-S7PROH-HD-L08E
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Applicant Contact STACY A KLUESNER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact STACY A KLUESNER
Regulation Number876.1500
Classification Product Code
FET  
Date Received10/24/2008
Decision Date 01/13/2009
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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