Astroglide Glycerin & Paraben Free

Lubricant, Personal

BioFilm Inc.

The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide Glycerin & Paraben Free.

Pre-market Notification Details

Device IDK220653
510k NumberK220653
Device Name:Astroglide Glycerin & Paraben Free
ClassificationLubricant, Personal
Applicant BioFilm Inc. 3225 Executive Ridge Vista,  CA  92081
ContactKevin Jamil
CorrespondentKevin Jamil
BioFilm Inc. 3225 Executive Ridge Vista,  CA  92081
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-05-06

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.