Astroglide O Oil Personal Lubricant & Massage Oil

Lubricant, Personal

BioFilm Inc.

The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide O Oil Personal Lubricant & Massage Oil.

Pre-market Notification Details

Device IDK171985
510k NumberK171985
Device Name:Astroglide O Oil Personal Lubricant & Massage Oil
ClassificationLubricant, Personal
Applicant BioFilm Inc. 3225 Executive Ridge Vista,  CA  92081
ContactRichard Hines
CorrespondentRichard Hines
BioFilm Inc. 3225 Executive Ridge Vista,  CA  92081
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-03
Decision Date2017-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00015594011417 K171985 000
00015594011738 K171985 000
00015594011844 K171985 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.