Astroglide Ultra Gentle Gel

Lubricant, Personal

BioFilm Inc.

The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide Ultra Gentle Gel.

Pre-market Notification Details

Device IDK220355
510k NumberK220355
Device Name:Astroglide Ultra Gentle Gel
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 Received2022-02-08
Decision Date2022-05-26

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