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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 K133336
Device Name PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
Applicant
PJUR GROUP,LUXEMBOURG S.A.
722 ARJEAN DR.
WILMINGTON,  NC  28411
Applicant Contact CANDACE CEDERMAN
Correspondent
PJUR GROUP,LUXEMBOURG S.A.
722 ARJEAN DR.
WILMINGTON,  NC  28411
Correspondent Contact CANDACE CEDERMAN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received10/29/2013
Decision Date 07/24/2014
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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