HEMOSIL FACTOR VII DEFICIENT PLASMA


Device Classification Name

plasma, coagulation factor deficient

510(k) Number K024082
Device Name HEMOSIL FACTOR VII DEFICIENT PLASMA
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol mable
Regulation Number 864.7290
Classification Product Code
GJT  
Date Received 12/11/2002
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No