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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K142790
Device Name OneTouch Lubricant Gel
Applicant
THAI NIPPON RUBBER INDUSTRY CO., LTD.
789/139 Pinthong Industrial Estate, Nongkham
Sriracha,  TH 20110
Applicant Contact Pisut Chanwatarungkull
Correspondent
EMERGO GROUP
816 CONGRESS AVENUE
SUITE 1400
AUSTIN,  TX  78701
Correspondent Contact Stuart R Goldman
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/26/2014
Decision Date 07/30/2015
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
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