The following data is part of a premarket notification filed by Trigg Laboratories Dba Wet International with the FDA for Wet Organics Personal Lubricant.
| Device ID | K182027 |
| 510k Number | K182027 |
| Device Name: | Wet Organics Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Trigg Laboratories DBA Wet International 4220 W Windmill Lane, Suite 140 Las Vegas, NV 89139 |
| Contact | Simone Buntin |
| Correspondent | Louie Goryoka Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-30 |
| Decision Date | 2018-11-21 |
| Summary: | summary |