The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Co., Ltd. with the FDA for Onetouch Lubricant Gel.
Device ID | K142790 |
510k Number | K142790 |
Device Name: | OneTouch Lubricant Gel |
Classification | Lubricant, Personal |
Applicant | THAI NIPPON RUBBER INDUSTRY CO., LTD. 789/139 Pinthong Industrial Estate, Nongkham Sriracha, TH 20110 |
Contact | Pisut Chanwatarungkull |
Correspondent | Stuart R Goldman EMERGO GROUP 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-26 |
Decision Date | 2015-07-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850281004415 | K142790 | 000 |