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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 K162235
Device Name LUVENA VAGINAL MOISTURIZER & LUBRICANT
Applicant
Laclede, Inc.
2103 E. University Dr.
Rancho Dominguez,  CA  90220
Applicant Contact MICHAEL PELLICO
Correspondent
Laclede, Inc.
2103 E. University Dr.
Rancho Dominguez,  CA  90220
Correspondent Contact MICHAEL PELLICO
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/09/2016
Decision Date 03/24/2017
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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