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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 K172473
Device Name LifeStyles® SKYN® Intimate Moments Personal Lubricant
Applicant
SXWELL USA LLC
111 Wood Avenue South, Suite 210
Iselin,  NJ  08830
Applicant Contact Robert Mahler
Correspondent
SXWELL USA LLC
111 Wood Avenue South, Suite 210
Iselin,  NJ  08830
Correspondent Contact Robert Mahler
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/15/2017
Decision Date 12/15/2017
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
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