Device Classification Name |
Plasma, Coagulation Factor Deficient
|
510(k) Number |
K031829 |
Device Name |
HEMOSIL FACTOR IX DEFICIENT PLASMA |
Applicant |
INSTRUMENTATION LABORATORY CO. |
526 RT. 303 |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
CAROL MARBLE |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
526 RT. 303 |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
CAROL MARBLE |
Regulation Number | 864.7290
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/13/2003 |
Decision Date | 07/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|