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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 K180083
Device Name Silicone Personal Lubricant, ALL-IN-ONE
Applicant
United Consortium
29000 N. Hancock Pkwy.
Valencia,  CA  91355
Applicant Contact Stephanie Morris
Correspondent
United Consortium
29000 N. Hancock Pkwy.
Valencia,  CA  91355
Correspondent Contact Stephanie Morris
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/11/2018
Decision Date 04/09/2018
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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