OneTouch Lubricant Gel

Lubricant, Personal

THAI NIPPON RUBBER INDUSTRY CO., LTD.

The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Co., Ltd. with the FDA for Onetouch Lubricant Gel.

Pre-market Notification Details

Device IDK142790
510k NumberK142790
Device Name:OneTouch Lubricant Gel
ClassificationLubricant, Personal
Applicant THAI NIPPON RUBBER INDUSTRY CO., LTD. 789/139 Pinthong Industrial Estate, Nongkham Sriracha,  TH 20110
ContactPisut Chanwatarungkull
CorrespondentStuart R Goldman
EMERGO GROUP 816 CONGRESS AVENUE SUITE 1400 Austin,  TX  78701
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-26
Decision Date2015-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850281004415 K142790 000

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