HEMOSIL FACTOR V DEFICIENT PLASMA


Device Classification Name

plasma, coagulation factor deficient

510(k) Number K023839
Device Name HEMOSIL FACTOR V DEFICIENT PLASMA
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol marble
Regulation Number 864.7290
Classification Product Code
GJT  
Date Received 11/18/2002
Decision Date 01/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No