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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lubricant, personal
510(k) Number K213671
Device Name Astroglide Sensual Strawberry Personal Lubricant
BioFilm Inc.
3225 Executive Ridge
Vista,  CA  92081
Applicant Contact Jennifer Keller
BioFilm Inc.
3225 Executive Ridge
Vista,  CA  92081
Correspondent Contact Jennifer Keller
Regulation Number884.5300
Classification Product Code
Date Received11/22/2021
Decision Date 03/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No