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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K121959
FOIA Releasable 510(k) K121959
Device Name EVIS EXERA III VIDEO SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLY,  PA  18034
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLY,  PA  18034
Correspondent Contact LAURA STORMS-TYLER
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
NWB  
Date Received07/05/2012
Decision Date 01/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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