FDA.reportPublic FDA data

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

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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