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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 K120650
Device Name POISE PERSONAL LUBRICANT
Original Applicant
KIMBERLY-CLARK CORPORATION
1400 holcomb bridge rd.
roswell,  GA  30076
Original Contact swarna mukund
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/02/2012
Decision Date 07/11/2012
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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