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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound Bronchoscope
510(k) Number K183525
Device Name EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachiochi-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Corporation OF The Americas
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact Sheri Musgnung
Regulation Number892.1550
Classification Product Code
PSV  
Subsequent Product Codes
ITX   IYN  
Date Received12/19/2018
Decision Date 09/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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