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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 K132954
Device Name JO PREMIUM PERSONAL LUBRICANT
Applicant
UNITED CONSORTIUM
29000 HANCOCK PKWY
VALENCIA,  CA  91355
Applicant Contact CRAIG MAY
Correspondent
UNITED CONSORTIUM
29000 HANCOCK PKWY
VALENCIA,  CA  91355
Correspondent Contact CRAIG MAY
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/20/2013
Decision Date 06/11/2014
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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