ASTROGLIDE NATURAL

Lubricant, Personal

BIOFILM, INC.

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

Pre-market Notification Details

Device IDK141581
510k NumberK141581
Device Name:ASTROGLIDE NATURAL
ClassificationLubricant, Personal
Applicant BIOFILM, INC. 3225 Executive Rdg Vista,  CA  92081
ContactSherry Castello
CorrespondentSherry Castello
BIOFILM, INC. 3225 Executive Rdg Vista,  CA  92081
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-13
Decision Date2014-08-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00015594010946 K141581 000

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