Device Classification Name |
pump, infusion
|
510(k) Number |
K021988 |
Device Name |
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM |
Applicant |
MEDRAD, INC. |
ONE MEDRAD DR. |
INDIANOLA,
PA
15051
|
|
Applicant Contact |
LORRAINE R FREDES |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/18/2002 |
Decision Date | 08/29/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|