ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

BIOFILM, INC.

The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide Ttc Fertility Friendly Personal Lubricant.

Pre-market Notification Details

Device IDK141132
510k NumberK141132
Device Name:ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
ClassificationLubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Applicant BIOFILM, INC. 3225 Executive Rdg Vista,  CA  92081
ContactSherry Castello
CorrespondentSherry Castello
BIOFILM, INC. 3225 Executive Rdg Vista,  CA  92081
Product CodePEB  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-01
Decision Date2015-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00015594011226 K141132 000

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