PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE

Lubricant, Personal

PJUR GROUP,LUXEMBOURG S.A.

The following data is part of a premarket notification filed by Pjur Group,luxembourg S.a. with the FDA for Pjur(r) Siliconegel, Pjur(r) Basic Personal Glide, Pjur(r) Light, Pjur(r) Med Premium Glide.

Pre-market Notification Details

Device IDK133336
510k NumberK133336
Device Name:PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
ClassificationLubricant, Personal
Applicant PJUR GROUP,LUXEMBOURG S.A. 722 ARJEAN DR. Wilmington,  NC  28411
ContactCandace Cederman
CorrespondentCandace Cederman
PJUR GROUP,LUXEMBOURG S.A. 722 ARJEAN DR. Wilmington,  NC  28411
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-29
Decision Date2014-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40827160112323 K133336 000
10827160115163 K133336 000
40827160106292 K133336 000
40827160111128 K133336 000
40827160111982 K133336 000
40827160111999 K133336 000
40827160112040 K133336 000
40827160112064 K133336 000
40827160112071 K133336 000
40827160112101 K133336 000
40827160112200 K133336 000
40827160112224 K133336 000
40827160112309 K133336 000
10827160115255 K133336 000

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