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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Biopsy, Bronchoscope (Non-Rigid)
510(k) Number K190293
Device Name Single Use Cytology Brush BC-205D
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachioji-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
Correspondent Contact Jonathan Gilbert
Regulation Number874.4680
Classification Product Code
BTG  
Date Received02/11/2019
Decision Date 08/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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