510(k) K260068

Device
pjur NATURE Touch, 100 ml
Applicant
Pjur Group Luxembourg S.A.
510(k) number
K260068
Product code
NUC
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-21
Date received
2026-01-09
Regulation
884.5300
Classification name
Lubricant, Personal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Andrea Giebel
Address
87, Esplanade De La Moselle Wasserbillig LU 6637 6637

FDA Registration Numbers

Source Documents

510(k) summary PDF

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