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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 K070587
Device Name ELEGANCE WOMAN'S LUBRICANT
Applicant
Julie Williams, Pa-C
1209 Robin Trail
Round Rock,  TX  78681
Applicant Contact JULIE WILLIAMS
Correspondent
Julie Williams, Pa-C
1209 Robin Trail
Round Rock,  TX  78681
Correspondent Contact JULIE WILLIAMS
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/01/2007
Decision Date 04/10/2008
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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