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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 and burn, hydrogel w/drug and/or biologic
510(k) Number K112568
Device Name AONGEN DENTAL COLLAGEN MATRIX
Original Applicant
AEON ASTRON EUROPE B.V.
niels bohrweg 11-13
leiden,  NL 2333 ca
Original Contact horng ji lai
Classification Product Code
MGQ  
Date Received09/06/2011
Decision Date 03/01/2012
Decision substantially equivalent (SESE)
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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