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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 K060145
Device Name FDS INTIMATE AND INTIMATE WARMING LUBRICANT
Applicant
Alberto-Culver USA, Inc.
2525 W. Armitage Ave.
Melrose Park,  IL  60148
Applicant Contact RICK MAIN
Correspondent
Alberto-Culver USA, Inc.
2525 W. Armitage Ave.
Melrose Park,  IL  60148
Correspondent Contact RICK MAIN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/19/2006
Decision Date 04/14/2006
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 Yes
Predetermined Change
Control Plan Authorized		 No
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