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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 K260068
Device Name pjur NATURE Touch, 100 ml
Applicant
Pjur Group Luxembourg S.A.
87, Esplanade De La Moselle
Wasserbillig,  LU 6637
Applicant Contact Andrea Giebel
Correspondent
Pjur Group Luxembourg S.A.
87, Esplanade De La Moselle
Wasserbillig,  LU 6637
Correspondent Contact Andrea Giebel
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/09/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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