Astroglide X Silicone Personal Lubricant

Lubricant, Personal

BioFilm Inc.

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

Pre-market Notification Details

Device IDK210242
510k NumberK210242
Device Name:Astroglide X Silicone Personal Lubricant
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 Received2021-01-29
Decision Date2021-04-28

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