DURAFIBER AG


Device Classification Name

dressing, wound, drug

510(k) Number K103793
Device Name DURAFIBER AG
Applicant
Smith & Nephew, Inc
970 lake carillon drive,
suite 110
st. petersburg, 
FL 
33716

Applicant Contact terry mcmahon
Correspondent
Smith & Nephew, Inc
970 lake carillon drive,
suite 110
st. petersburg, 
FL 
33716

Correspodent Contact terry mcmahon
Classification Product Code
FRO  
Date Received 12/27/2010
Decision Date 05/02/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes