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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 K171701
Device Name GelPOINT Path Transanal Access Platform
Applicant
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact Corinne Weisheit
Correspondent
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact Corinne Weisheit
Regulation Number876.1500
Classification Product Code
FER  
Date Received06/08/2017
Decision Date 07/20/2017
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
Recalls CDRH Recalls
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