WOUNDSTAT


Device Classification Name

dressing, wound, drug

510(k) Number K081183
Device Name WOUNDSTAT
Applicant
TRAUMACURE INC.
2001 pennsylvania ave.
suite 950
washington, 
DC 
20006

Applicant Contact campbell hutton
Correspondent
TRAUMACURE INC.
2001 pennsylvania ave.
suite 950
washington, 
DC 
20006

Correspodent Contact campbell hutton
Classification Product Code
FRO  
Date Received 04/25/2008
Decision Date 06/19/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes