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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 K051668
Device Name THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
Applicant
GOODMARK USA, INC.
12 BLENDON WOODS DRIVE
SOUTHBOROUGH,  MA  01772
Applicant Contact ROBERT J MICHALIK
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 Received06/22/2005
Decision Date 07/08/2005
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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