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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 K200397
Device Name Single Use Biopsy Forceps FB-456D
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachiochi-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Coprporation of the Americas
3500 Corporation Pkwy. P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact Jonathan Gilbert
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received02/18/2020
Decision Date 04/24/2020
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
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