SURGISIS STAPLE LINE REINFORCEMENT


Device Classification Name

mesh, surgical, collagen, staple line reinforcement

510(k) Number K022044
Device Name SURGISIS STAPLE LINE REINFORCEMENT
Original Applicant
COOK BIOTECH, INC.
3055 kent ave.
west lafayette, 
IN 
47906 -1076

Original Contact mark bleyer
Regulation Number 878.3300
Classification Product Code
OXE  
Subsequent Product Codes
FTM   PAJ  
Date Received 06/24/2002
Decision Date 08/23/2002
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

Category: Uncategorized