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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 K160717
Device Name ally Warming Liquid Personal Lubricant
Applicant
GUY & O'NEILL, INC.
200 INDUSTRIAL DRIVE
FREDONIA,  WI  53021
Applicant Contact THOMAS MISGEN
Correspondent
SPECTRAMEDEX, LLC
3215 GOLF ROAD, #149
DELAFIELD,  WI  53018
Correspondent Contact JOHN ZIOBRO
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/15/2016
Decision Date 06/14/2016
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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