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 |