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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culdoscope (And Accessories)
510(k) Number K143308
Device Name GelPOINT Transvaginal Access Platform
Applicant
Applied Medical Resources
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact Frans VandenBroek
Correspondent
Applied Medical Resources
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact Frans VandenBroek
Regulation Number884.1640
Classification Product Code
HEW  
Date Received11/18/2014
Decision Date 10/13/2015
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
Predetermined Change
Control Plan Authorized		 No
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