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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 K140193
Device Name DUREX EMBRACE PERSONAL LUBRICANT
Applicant
RECKITT BENCKISER, LLC
399 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Applicant Contact SAPANA AMIN
Correspondent
RECKITT BENCKISER, LLC
399 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Correspondent Contact SAPANA AMIN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/27/2014
Decision Date 11/04/2014
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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