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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 K212260
Device Name Sensuva Premium Silicone Personal Lubricant
Applicant
Valencia Naturals, Inc.
9731 Topanga Canyon Place
Chatsworth,  CA  91311
Applicant Contact Anthony Santoro
Correspondent
Slmco, Inc.
19762 Steinway St.
Canyon Country,  CA  91351
Correspondent Contact Stephanie Morris
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/20/2021
Decision Date 04/13/2022
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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