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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 K163674
Device Name Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
Applicant
NEO COSMETIQUE
15 RUE MONTJOIE
SAINT DENIS,  FR 93212
Applicant Contact NATHALIE VERNIN
Correspondent
TECHNIC INC
47 MOLTER AVE
CRANSTON,  RI  02910
Correspondent Contact GAYLE LYNE
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/27/2016
Decision Date 09/22/2017
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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