GLYCERIN & PARABEN FREE ASTROGLIDE

Lubricant, Personal

BIOFILM, INC.

The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Glycerin & Paraben Free Astroglide.

Pre-market Notification Details

Device IDK072647
510k NumberK072647
Device Name:GLYCERIN & PARABEN FREE ASTROGLIDE
ClassificationLubricant, Personal
Applicant BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista,  CA  92081
ContactRobert De Armond
CorrespondentRobert De Armond
BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista,  CA  92081
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-19
Decision Date2008-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00015594011882 K072647 000
00015594010632 K072647 000
00015594011929 K072647 000
00015594011776 K072647 000

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