DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)


Device Classification Name

dressing, wound, drug

510(k) Number K080497
Device Name DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
Applicant
DERMA SCIENCES CANADA, INC.
104 shorting rd.
toronto, ontario, 

CA

m1s 3s4

Applicant Contact sharmini atheray
Correspondent
DERMA SCIENCES CANADA, INC.
104 shorting rd.
toronto, ontario, 

CA

m1s 3s4

Correspodent Contact sharmini atheray
Classification Product Code
FRO  
Date Received 02/22/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes