HEMO-BARRIER


Device Classification Name

bandage, liquid

510(k) Number K953500
Device Name HEMO-BARRIER
Applicant
ASIA DYNAMICS, INC.
5745 west howard st.
niles, 
IL 
60714

Applicant Contact christi gerard
Correspondent
ASIA DYNAMICS, INC.
5745 west howard st.
niles, 
IL 
60714

Correspodent Contact christi gerard
Regulation Number 880.5090
Classification Product Code
KMF  
Date Received 07/26/1995
Decision Date 01/24/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No