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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 K210242
Device Name Astroglide X Silicone Personal Lubricant
Applicant
BioFilm Inc.
3225 Executive Ridge
Vista,  CA  92081
Applicant Contact Kevin Jamil
Correspondent
BioFilm Inc.
3225 Executive Ridge
Vista,  CA  92081
Correspondent Contact Kevin Jamil
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/29/2021
Decision Date 04/28/2021
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
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