SIS PLASTIC SURGERY MATRIX

Device Classification Name

mesh, surgical

510(k) Number K034039
Device Name SIS PLASTIC SURGERY MATRIX
Applicant
COOK BIOTECH, INC.
3055 kent ave.
west lafayette, 
IN 
47906 -1076

Applicant Contact mark bleyer
Correspondent
COOK BIOTECH, INC.
3055 kent ave.
west lafayette, 
IN 
47906 -1076

Correspodent Contact mark bleyer
Regulation Number 878.3300
Classification Product Code
FTM  
Date Received 12/29/2003
Decision Date 02/18/2004
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