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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K221557
Device Name Visera Hysterovideoscope Olympus HYF Type V
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-cho, Hachioji-shi
Tokyo,  JP
Applicant Contact Toshio Nakamura
Correspondent
Olympus Corporation of the Americas
800 West Park Drive
Westborough,  MA  01581
Correspondent Contact Gary Brennan
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/31/2022
Decision Date 09/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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