Device Classification Name |
Plasma, Coagulation Factor Deficient
|
510(k) Number |
K024082 |
Device Name |
HEMOSIL FACTOR VII DEFICIENT PLASMA |
Applicant |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Applicant Contact |
CAROL MABLE |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
CAROL MABLE |
Regulation Number | 864.7290
|
Classification Product Code |
|
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
|
|
|