HEMCON HEMOSTATIC GEL


Device Classification Name

dressing, wound, drug

510(k) Number K112215
Device Name HEMCON HEMOSTATIC GEL
Applicant
HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD.
10575 sw cascade avenue, suite 130
portland, 
OR 

Applicant Contact kendra rathkey
Correspondent
HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD.
10575 sw cascade avenue, suite 130
portland, 
OR 

Correspodent Contact kendra rathkey
Classification Product Code
FRO  
Date Received 08/02/2011
Decision Date 04/12/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No