PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!

Lubricant, Personal

PJUR GROUP LUXEMBOURG SA

The following data is part of a premarket notification filed by Pjur Group Luxembourg Sa with the FDA for Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide And Analyse Me!.

Pre-market Notification Details

Device IDK141913
510k NumberK141913
Device Name:PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
ClassificationLubricant, Personal
Applicant PJUR GROUP LUXEMBOURG SA 722 ARJEAN DRIVE Wilmington,  NC  28411
ContactCandace F Cederman
CorrespondentCandace F Cederman
PJUR GROUP LUXEMBOURG SA 722 ARJEAN DRIVE Wilmington,  NC  28411
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-15
Decision Date2015-04-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40827160112590 K141913 000
40827160112255 K141913 000
40827160112248 K141913 000
40827160112149 K141913 000
40827160112132 K141913 000
40827160111920 K141913 000
40827160111098 K141913 000
10827160116771 K141913 000
00827160116750 K141913 000

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