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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 K062682
Device Name CVS PERSONAL LUBRICANT AND MOISTURIZER
Applicant
Lake Consumer Products, Inc.
1 Pharmacal Way
Jackson,  WI  53037
Applicant Contact MARY L WUNDROCK
Correspondent
Lake Consumer Products, Inc.
1 Pharmacal Way
Jackson,  WI  53037
Correspondent Contact MARY L WUNDROCK
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/08/2006
Decision Date 04/04/2007
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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