Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant

Lubricant, Personal

United Consortium

The following data is part of a premarket notification filed by United Consortium with the FDA for Bucked Stride Silicone Lubricant, #lubelife Thin Silicone Lubricant, Jo Xtra Silky Ultra-thin Silicone Personal Lubricant.

Pre-market Notification Details

Device IDK190858
510k NumberK190858
Device Name:Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
ClassificationLubricant, Personal
Applicant United Consortium 29000 N. Hancock Pkwy. Valencia,  CA  91355
ContactStephanie Morris
CorrespondentMarlent Perez
United Consortium 29000 N. Hancock Pkwy. Valencia,  CA  91355
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-02
Decision Date2019-09-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10796494001896 K190858 000
10796494001339 K190858 000
10796494003999 K190858 000
10796494002206 K190858 000
10796494002350 K190858 000
10796494003609 K190858 000
10796494003623 K190858 000
10796494001872 K190858 000
00796494001882 K190858 000
10796494001322 K190858 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.