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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 K203644
Device Name Solevy Co. LLC Silicone Based Personal Lubricant
Applicant
Solevy Co., LLC
29017 Ave. Penn
Valencia,  CA  91355
Applicant Contact Joe Mendoza
Correspondent
Solevy Co., LLC
29017 Ave. Penn
Valencia,  CA  91355
Correspondent Contact Joe Mendoza
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/14/2020
Decision Date 04/19/2021
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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