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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 K133393
Device Name GELPOINT PATH TRANSANAL ACCESS PLATFORM
Applicant
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact FRANS VANDENBROEK
Correspondent
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact FRANS VANDENBROEK
Regulation Number876.1500
Classification Product Code
FER  
Date Received11/05/2013
Decision Date 01/02/2014
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
Predetermined Change
Control Plan Authorized		 No
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