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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 K110691
Device Name ONE PERSONAL LUBRICANT (WATER BASED)
Applicant
ONE
12 CHANNEL STREET
BOSTON,  MA  02210
Applicant Contact SHARON PIETILA
Correspondent
ONE
12 CHANNEL STREET
BOSTON,  MA  02210
Correspondent Contact SHARON PIETILA
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/11/2011
Decision Date 02/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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