Flip Lube

Lubricant, Personal

Imquest Biosciences Inc.

The following data is part of a premarket notification filed by Imquest Biosciences Inc. with the FDA for Flip Lube.

Pre-market Notification Details

Device IDK171516
510k NumberK171516
Device Name:Flip Lube
ClassificationLubricant, Personal
Applicant Imquest Biosciences Inc. 7340 Executive Way, Suite R Frederick,  MD  21704
ContactKaren W. Buckheit
CorrespondentPaul Dryden
ImQuest Biosciences, Inc. C/o ProMedical LLC 24301 Woodsage Dr. Bonita Springs,  FL  34134 -2958
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-24
Decision Date2018-02-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853517007020 K171516 000
00853517007013 K171516 000

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