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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 K162569
FOIA Releasable 510(k) K162569
Device Name YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
Applicant
Biotech Lubricants, Ltd.
Trademark House, Ramshill
Petersfield,  GB GU31 4AT
Applicant Contact Sarah Brooks
Correspondent
Maetrics
Biocity Nottingham, Pennyfoot St.
Nottingham,  GB NG1 1GF
Correspondent Contact Karen Cornelius
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/15/2016
Decision Date 06/09/2017
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
Predetermined Change
Control Plan Authorized		 No
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