Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K905447 |
Device Name |
E-Z-EM PULSED INFUSION SYSTEM |
Applicant |
E-Z-EM, INC. |
373 PLANTATION ST. |
WORCESTER,
MA
01605
|
|
Applicant Contact |
GEORGANNE BROWN |
Correspondent |
E-Z-EM, INC. |
373 PLANTATION ST. |
WORCESTER,
MA
01605
|
|
Correspondent Contact |
GEORGANNE BROWN |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 12/05/1990 |
Decision Date | 04/01/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|