GUARDACARE


Device Classification Name

dressing, wound, drug

510(k) Number K103641
Device Name GUARDACARE
Applicant
HEMCON MEDICAL TECHNOLOGIES, INC.
10575 sw cascade avenue
suite 130
portland, 
OR 
97223 -4363

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

Correspodent Contact kevin hawkins
Classification Product Code
FRO  
Date Received 12/13/2010
Decision Date 06/16/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes