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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, Gamete, Fertilization, And Embryo Compatible
510(k) Number K182585
Device Name JO Actively Trying Personal Lubricant
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
PEB  
Date Received09/20/2018
Decision Date 04/26/2019
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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