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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 K101585
Device Name K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
Applicant
Johnson & Johnson Consumer & Personal Products Wor
185 Tabor Rd.
Morris Plains,  NJ  07950
Applicant Contact BRAD LAMOTTE,PHARM.D.
Correspondent
Johnson & Johnson Consumer & Personal Products Wor
185 Tabor Rd.
Morris Plains,  NJ  07950
Correspondent Contact BRAD LAMOTTE,PHARM.D.
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/07/2010
Decision Date 05/10/2011
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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