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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anoscope and accessories
510(k) Number K200021
Device Name Applied Medical Anoscope
Applicant
Applied Medical Resources
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact Frans VandenBroek
Correspondent
Applied Medical Resources
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact Aeree Lee
Regulation Number876.1500
Classification Product Code
FER  
Date Received01/06/2020
Decision Date 01/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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