Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Ave. 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
Predetermined Change
Control Plan Authorized		 No
-
-