ASTROGLIDE SENSUAL STRAWBERRY

Lubricant, Personal

BIOFILM, INC.

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

Pre-market Notification Details

Device IDK140590
510k NumberK140590
Device Name:ASTROGLIDE SENSUAL STRAWBERRY
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 Received2014-03-07
Decision Date2014-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00015594010540 K140590 000
00015594012056 K140590 000

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