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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 K242712
Device Name LubriZenzs
Applicant
Sk Zen, LLC
1264 Bayview Cir.
Weston,  FL  33326
Applicant Contact Yasminka Jurisic
Correspondent
Compliance4Devices
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/09/2024
Decision Date 06/04/2025
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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