Pjur WOMAN Nude Pjur Med SENSITIVE Glide

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 Woman Nude Pjur Med Sensitive Glide.

Pre-market Notification Details

Device IDK200730
510k NumberK200730
Device Name:Pjur WOMAN Nude Pjur Med SENSITIVE Glide
ClassificationLubricant, Personal
Applicant pjur Group Luxembourg SA 87 Esplanade De La Moselle Wasserbillig,  LU L-6637
ContactAndrea Giebel
CorrespondentCandace Cederman
Candace F. Cederman 722 Arjean Drive Wilmington,  NC  28411
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-20
Decision Date2020-12-17

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