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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 K051688
Device Name FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
Applicant
TRIMENSA PHARMACEUTICALS
1050 LAWRENCE DR.
NEWBURY PARK,  CA  91320
Applicant Contact ROBIN J OGILVIE
Correspondent
TRIMENSA PHARMACEUTICALS
1050 LAWRENCE DR.
NEWBURY PARK,  CA  91320
Correspondent Contact ROBIN J OGILVIE
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/23/2005
Decision Date 07/12/2006
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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