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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 K152168
Device Name Love Liquid Personal Lubricant
Applicant
The Kama Sutra Company
2151 Anchor Court
Thousand Oaks,  CA  91320
Applicant Contact Marla Lee
Correspondent
MED-DEVICE CONSULTING, INC.
5804 RAINBOW HILL RD.
AGOURA HILLS,  CA  91301
Correspondent Contact LOUIE GORYOKA
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/04/2015
Decision Date 02/05/2016
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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