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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 K200602
Device Name Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
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 Received03/09/2020
Decision Date 06/03/2020
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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