MATRISTEM WOUND MATRIX


Device Classification Name

dressing, wound, collagen

510(k) Number K112409
Device Name MATRISTEM WOUND MATRIX
Applicant
ACELL, INC
6640 eli whitney drive
suite 200
columbia, 
MD 
21046

Applicant Contact deborah a baker-janis
Correspondent
ACELL, INC
6640 eli whitney drive
suite 200
columbia, 
MD 
21046

Correspodent Contact deborah a baker-janis
Classification Product Code
KGN  
Date Received 08/22/2011
Decision Date 08/29/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No