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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 K140304
Device Name SIMPLY SLICK PERSONAL LUBRICATING LOTION
Applicant
SIMPLY SOLUTIONS, LLC
2949 VENTURE DR., STE 170
JANESVILLE,  WI  53546 -8501
Applicant Contact JOHN GOEPFERT
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 Received02/07/2014
Decision Date 10/07/2014
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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