FDA.report

510(k) K243415

Device
Granudacyn® Wound Irrigation Solution
Applicant
P.G.F. Industry Solutions GmbH
510(k) number
K243415
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-22
Date received
2024-11-01
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Peter Fritz
Address
Katzmoosstraße 26a 5161 Elixhausen AT 5161 5161

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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