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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 K180014
Device Name Creme de La Femme Feminine Lubricant
Applicant
Cewal, Inc. Dba Premiere Enterprises
2806 Oakhurst Ave.
Los Angeles,  CA  90034
Applicant Contact Jerome Vozoff
Correspondent
Amin Talati Upadhye, Llp
100 S Wacker Dr. Suite 2000
Chicago,  IL  60606
Correspondent Contact Abhishek Gurnani
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/02/2018
Decision Date 12/21/2018
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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