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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K250263
Device Name Disposable Grasping Forceps FG-52D/FG-54D
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachiochi-Shi,  JP 192-8507
Applicant Contact Seiko Yunoki
Correspondent
Olympus Corporation of the Americas
800 W Park Dr.
Westborough,  MA  01581
Correspondent Contact Roshana Ahmed
Regulation Number874.4680
Classification Product Code
KTI  
Date Received01/29/2025
Decision Date 03/31/2025
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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