Device Classification Name |
arterial blood sampling kit
|
510(k) Number |
K875117 |
Device Name |
CIBA CORNING BALANCED HEPARIN FOR CA++ |
Applicant |
CIBA CORNING DIAGNOSTICS CORP. |
333 CONEY ST. |
E. WALPOLE,
MA
02032
|
|
Applicant Contact |
William J Pignato |
Correspondent |
CIBA CORNING DIAGNOSTICS CORP. |
333 CONEY ST. |
E. WALPOLE,
MA
02032
|
|
Correspondent Contact |
William J Pignato |
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 12/15/1987 |
Decision Date | 02/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|