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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 K200731
Device Name pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
Applicant
Pjur Group Luxembourg S.A.
87 Esplanade De La Moselle
Wasserbillig,  LU L-6637
Applicant Contact Andrea Giebel
Correspondent
Candace F. Cederman
722 Arjean Dr.
Wilmington,  NC  28411
Correspondent Contact Candace Cederman
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/20/2020
Decision Date 01/21/2021
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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