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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 K202445
Device Name Hystero-V Hysteroscope
Applicant
Hysterovue, Inc.
5337 14th Pl. SE
Bellevue,  WA  98006
Applicant Contact Thomas Lawson
Correspondent
Hysterovue, Inc.
5337 14th Pl. SE
Bellevue,  WA  98006
Correspondent Contact Thomas Lawson
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/26/2020
Decision Date 11/23/2021
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
Predetermined Change
Control Plan Authorized		 No
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