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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K243415
Device Name Granudacyn® Wound Irrigation Solution
Applicant
P.G.F. Industry Solutions GmbH
Katzmoosstraße 26a
5161
Elixhausen,  AT 5161
Applicant Contact Peter Fritz
Correspondent
Molnlycke Health Care Us, LLC
5445 Triangle Pkwy.
Suite 400
Peachtree Corners,  GA  30092
Correspondent Contact Leonard Stewart
Classification Product Code
FRO  
Date Received11/01/2024
Decision Date 07/22/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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