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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 K171044
Device Name Climax Personal Lubricant
Applicant
WSM Investment LLC, dba Topco Sales
3990 Suite B
Heritage Oak Court
Simi Valley,  CA  93063
Applicant Contact Adrian Mendoza
Correspondent
WSM Investment LLC, dba Topco Sales
3990 Suite B
Heritage Oak Court
Simi Valley,  CA  93063
Correspondent Contact Julie Casagrande
Regulation Number884.5300
Classification Product Code
NUC  
Date Received04/07/2017
Decision Date 11/21/2017
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
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