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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 K141767
Device Name ID MILLENNIUM, ID MOMENTS SILICONE
Applicant
WESTRIDGE LABORATORIES, INC.
27001 LA PAZ ROAD, SUITE 312
MISSION VIEJO,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
WESTRIDGE LABORATORIES, INC.
27001 LA PAZ ROAD, SUITE 312
MISSION VIEJO,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/01/2014
Decision Date 03/09/2015
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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