CHITOGAUZE FUSION


Device Classification Name

dressing, wound, drug

510(k) Number K111163
Device Name CHITOGAUZE FUSION
Applicant
HEMCON MEDICAL TECHNOLOGIES, INC.
10575 sw cascade avenue
suite 130
portland, 
OR 
97223 -4363

Applicant Contact kendra rathkey
Correspondent
HEMCON MEDICAL TECHNOLOGIES, INC.
10575 sw cascade avenue
suite 130
portland, 
OR 
97223 -4363

Correspodent Contact kendra rathkey
Classification Product Code
FRO  
Date Received 04/26/2011
Decision Date 05/17/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes