AONGEN COLLAGEN MATRIX


Device Classification Name

dressing, wound, collagen

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

Correspodent Contact horng j lai
Classification Product Code
KGN  
Date Received 03/28/2008
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