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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 K211227
Device Name HTx Disposable Hysteroscope System
Applicant
AcuVu Inc.
4546 El Camino Real #211
Los Altos,  CA  94022
Applicant Contact Sam Mostafavi
Correspondent
AcuVu Inc.
4546 El Camino Real #211
Los Altos,  CA  94022
Correspondent Contact Sam Mostafavi
Regulation Number884.1690
Classification Product Code
HIH  
Date Received04/23/2021
Decision Date 09/15/2021
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
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