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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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