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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
Private Label Production, LLC
28790 S. Diesel Dr., Suite 11
Bonita Spring,  FL  34135
Applicant Contact Frank Koretsky
Correspondent
Private Label Production, LLC
28790 S. Diesel Dr., Suite 11
Bonita Spring,  FL  34135
Correspondent Contact Frank Koretsky
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
Predetermined Change
Control Plan Authorized		 No
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