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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 K150480
Device Name JO H20 Water Based Personal Lubricant
Applicant
UNITED CONSORTIUM INC.
29000 HANCOCK PKWY
VALENCIA,  CA  91355
Applicant Contact Joe Mendoza
Correspondent
UNITED CONSORTIUM Inc.
29000 HANCOCK PKWY
VALENCIA,  CA  91355
Correspondent Contact Joe Mendoza
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/24/2015
Decision Date 07/08/2015
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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