HEMOSIL FACTOR VIII DEFICIENT PLASMA


Device Classification Name

plasma, coagulation factor deficient

510(k) Number K034007
Device Name HEMOSIL FACTOR VIII DEFICIENT PLASMA
Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Applicant Contact carol marble
Correspondent
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Correspodent Contact carol marble
Regulation Number 864.7290
Classification Product Code
GJT  
Date Received 12/24/2003
Decision Date 02/13/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No