BIODESIGN NIPPLE RECONSTRUCTION CYLINDER


Device Classification Name

mesh, surgical

510(k) Number K110402
Device Name BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
Applicant
COOK BIOTECH, INC.
1425 innovation place
west lafayette, 
IN 
47906 -1000

Applicant Contact perry w guinn
Correspondent
COOK BIOTECH, INC.
1425 innovation place
west lafayette, 
IN 
47906 -1000

Correspodent Contact perry w guinn
Regulation Number 878.3300
Classification Product Code
FTM  
Date Received 02/11/2011
Decision Date 06/20/2011
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