ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT

Condom

BIOFILM, INC.

The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide Brand Warming Liquid Personal Lubricant.

Pre-market Notification Details

Device IDK041432
510k NumberK041432
Device Name:ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
ClassificationCondom
Applicant BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista,  CA  92081
ContactRobert L De Armond
CorrespondentRobert L De Armond
BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista,  CA  92081
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-28
Decision Date2004-11-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00015594010342 K041432 000
00015594011967 K041432 000

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