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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K080868
Device Name AONGEN COLLAGEN MATRIX
Applicant
Aeon Astron Europe B.V.
Niels Bohrweg 11-13
Leiden,  NL 2333
Applicant Contact HORNG J LAI
Correspondent
Aeon Astron Europe B.V.
Niels Bohrweg 11-13
Leiden,  NL 2333
Correspondent Contact HORNG J LAI
Classification Product Code
KGN  
Date Received03/28/2008
Decision Date 05/14/2009
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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