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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 K101241
FOIA Releasable 510(k) K101241
Device Name REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
Applicant
LIL DRUG STORE PRODUCTS, INC.
1201 CONTINENTAL PL. N.E.
CEDAR RAPIDS,  IA  52402
Applicant Contact PATRICIA L MILLER
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number884.5300
Classification Product Code
NUC  
Date Received05/04/2010
Decision Date 08/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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