Pjur WOMAN Aloe, Pjur Analyse Me! Water-based, Pjur BACK DOOR Water-based, Pjur Med Moisturising Glide,pjur Med NATURAL Glide, We-Vibe Lube Made By Pjur

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 Aloe, Pjur Analyse Me! Water-based, Pjur Back Door Water-based, Pjur Med Moisturising Glide,pjur Med Natural Glide, We-vibe Lube Made By Pjur.

Pre-market Notification Details

Device IDK200527
510k NumberK200527
Device Name:Pjur WOMAN Aloe, Pjur Analyse Me! Water-based, Pjur BACK DOOR Water-based, Pjur Med Moisturising Glide,pjur Med NATURAL Glide, We-Vibe Lube Made By Pjur
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 Received2020-03-02
Decision Date2021-02-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10827160115071 K200527 000
10827160115040 K200527 000
10827160115002 K200527 000
10827160114999 K200527 000
10827160115187 K200527 000
10827160116290 K200527 000
10827160116276 K200527 000

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