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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 K151647
Device Name Uberlube
Applicant
UBERLUBE LLC
2611 HARTZELL STREET
EVANSTON,  IL  60201
Applicant Contact JACK MAGNUSEN
Correspondent
SPECTRAMEDEX LLC
117 WEST SOUTH STREET
OCONOMOWOC,  WI  53066
Correspondent Contact JOHN ZIOBRO
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/18/2015
Decision Date 09/23/2015
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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