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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 K210972
Device Name H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two
Applicant
Cc Wellness, LLC
29000 N. Hancock Pkwy.
Valencia,  CA  91344
Applicant Contact Marlent Perez
Correspondent
Cc Wellness, LLC
29000 N. Hancock Pkwy.
Valencia,  CA  91344
Correspondent Contact Marlent Perez
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/31/2021
Decision Date 06/10/2021
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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