Wet Water Based Personal Lubricant (additionally, Branded As WET Platinum Houston, Elite Water-Based Hybrid)

Lubricant, Personal

Trigg Laboratories, Inc. D/B/A Wet International

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).

Pre-market Notification Details

Device IDK191480
510k NumberK191480
Device Name:Wet Water Based Personal Lubricant (additionally, Branded As WET Platinum Houston, Elite Water-Based Hybrid)
ClassificationLubricant, Personal
Applicant Trigg Laboratories, Inc. D/B/A Wet International 4220 W Windmill Lane, Suite 140 Las Vegas,  CA  89139
ContactLouie Goryoka
CorrespondentLouie Goryoka
Trigg Laboratories, Inc. D/B/A Wet International 4220 W Windmill Lane, Suite 140 Las Vegas,  CA  89139
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2019-10-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00716222272087 K191480 000
00716222272063 K191480 000
00716222272049 K191480 000
00716222272025 K191480 000

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