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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 K243380
Device Name VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 92-8507
Applicant Contact Toshio Nakamura
Correspondent
Olympus Surgical Technologies of the Americas
800 W Park Dr.
Westborough,  MA  01581
Correspondent Contact Wendy Perrreault
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Codes
EOQ   EQL   HET   NTN   NWB  
Date Received10/30/2024
Decision Date 03/03/2025
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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