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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 K080978
Device Name WALGREEN'S PERSONAL LUBRICATING JELLY
Applicant
TOPCO SALES
9401 DE SOTO AVE.
CHATSWORTH,  CA  91311
Applicant Contact LORELEI CHAVEZ
Correspondent
TOPCO SALES
9401 DE SOTO AVE.
CHATSWORTH,  CA  91311
Correspondent Contact LORELEI CHAVEZ
Regulation Number884.5300
Classification Product Code
NUC  
Subsequent Product Code
HIS  
Date Received04/07/2008
Decision Date 04/23/2009
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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