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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K221660
Device Name RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi,  JP 192-8507
Applicant Contact Shinichiro Kawachi
Correspondent
Olympus Corporation of the Americas
800 West Park Drive
Westborough,  MA  01581
Correspondent Contact Steven W Keenan
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/08/2022
Decision Date 12/28/2022
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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