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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 K141913
Device Name PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
Applicant
Pjur Group Luxembourg S.A.
722 Arjean Dr.
Wilmington,  NC  28411
Applicant Contact CANDACE F CEDERMAN
Correspondent
Pjur Group Luxembourg S.A.
722 Arjean Dr.
Wilmington,  NC  28411
Correspondent Contact CANDACE F CEDERMAN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/15/2014
Decision Date 04/06/2015
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
Predetermined Change
Control Plan Authorized		 No
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