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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vaginoscope and accessories
510(k) Number K220969
Device Name GelPOINT V-Path Vaginal Access System
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact David Yu
Correspondent
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact David Yu
Regulation Number884.1630
Classification Product Code
MOK  
Date Received04/04/2022
Decision Date 09/16/2022
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
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