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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 K200114
Device Name Astroglide Organix Liquid
BioFilm Inc
3225 Executive Ridge
Vista,  CA  92081
Applicant Contact Richard Hines
BioFilm Inc
3225 Executive Ridge
Vista,  CA  92081
Correspondent Contact Richard Hines
Regulation Number884.5300
Classification Product Code
Date Received01/21/2020
Decision Date 10/13/2020
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