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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, collagen
510(k) Number K173223
Device Name ologen Collagen Matrix
Applicant
Aeon Astron Europe B.V.
J.H. Oortweg 19
leiden,  NL 2333 ch
Applicant Contact horng ji lai
Correspondent
Aeon Astron Europe B.V.
J.H. Oortweg 19
leiden,  NL 2333 ch
Correspondent Contact horng ji lai
Classification Product Code
KGN  
Date Received10/03/2017
Decision Date 03/02/2018
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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