Astroglide Sensual Strawberry Personal Lubricant

Lubricant, Personal

BioFilm Inc.

The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide Sensual Strawberry Personal Lubricant.

Pre-market Notification Details

Device IDK213671
510k NumberK213671
Device Name:Astroglide Sensual Strawberry Personal Lubricant
ClassificationLubricant, Personal
Applicant BioFilm Inc. 3225 Executive Ridge Vista,  CA  92081
ContactJennifer Keller
CorrespondentJennifer Keller
BioFilm Inc. 3225 Executive Ridge Vista,  CA  92081
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-22
Decision Date2022-03-03

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