Device Classification Name |
injector and syringe, angiographic
|
510(k) Number |
K875196 |
Device Name |
DISPOSABLE CORONARY CONTROL SYRINGE 12CC |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
P.O. BOX 17484 |
SALT LAKE CITY,
UT
84117
|
|
Applicant Contact |
FRED LAMPROPOULOS |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
P.O. BOX 17484 |
SALT LAKE CITY,
UT
84117
|
|
Correspondent Contact |
FRED LAMPROPOULOS |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 12/17/1987 |
Decision Date | 02/11/1988 |
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
|
|
|