Device Classification Name |
syringe, piston
|
510(k) Number |
K883094 |
Device Name |
MX350 (SERIES) CONTROL SYRINGE |
Applicant |
MEDEX, INC. |
3637 LACON RD. |
HILLARD,
OH
43026
|
|
Applicant Contact |
CLINT R LAWSON |
Correspondent |
MEDEX, INC. |
3637 LACON RD. |
HILLARD,
OH
43026
|
|
Correspondent Contact |
CLINT R LAWSON |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 07/22/1988 |
Decision Date | 08/10/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|