The following data is part of a premarket notification filed by Trigg Laboratories, Inc. D/b/a Wet International with the FDA for Wet Water Based Personal Lubricant (additionally, Branded As Wet Platinum Houston, Elite Water-based Hybrid).
Device ID | K191480 |
510k Number | K191480 |
Device Name: | Wet Water Based Personal Lubricant (additionally, Branded As WET Platinum Houston, Elite Water-Based Hybrid) |
Classification | Lubricant, Personal |
Applicant | Trigg Laboratories, Inc. D/B/A Wet International 4220 W Windmill Lane, Suite 140 Las Vegas, CA 89139 |
Contact | Louie Goryoka |
Correspondent | Louie Goryoka Trigg Laboratories, Inc. D/B/A Wet International 4220 W Windmill Lane, Suite 140 Las Vegas, CA 89139 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-04 |
Decision Date | 2019-10-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00716222272087 | K191480 | 000 |
00716222272063 | K191480 | 000 |
00716222272049 | K191480 | 000 |
00716222272025 | K191480 | 000 |