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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 K200457
Device Name Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
Applicant
CC Wellness LLC
29000 N. Hancock Pkwy.
Valencia,  CA  91355
Applicant Contact Marlent Perez
Correspondent
CC Wellness LLC
29000 N. Hancock Pkwy.
Valencia,  CA  91355
Correspondent Contact Marlent Perez
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/25/2020
Decision Date 05/22/2020
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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