SURGISIS BIODESIGN TISSUE GRAFT


Device Classification Name

mesh, surgical

510(k) Number K073391
Device Name SURGISIS BIODESIGN TISSUE GRAFT
Applicant
COOK BIOTECH, INC.
1425 innovation place
west lafayette, 
IN 
47906 -1000

Applicant Contact mary a faderan
Correspondent
COOK BIOTECH, INC.
1425 innovation place
west lafayette, 
IN 
47906 -1000

Correspodent Contact mary a faderan
Regulation Number 878.3300
Classification Product Code
FTM  
Date Received 12/03/2007
Decision Date 03/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No