Device Classification Name |
syringe, piston
|
510(k) Number |
K991758 |
Device Name |
MONOJECT INSULIN SYRINGE |
Applicant |
THE KENDAL CO. |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048 -1108
|
|
Applicant Contact |
FRANK J FUCILE |
Correspondent |
THE KENDAL CO. |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048 -1108
|
|
Correspondent Contact |
FRANK J FUCILE |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 05/24/1999 |
Decision Date | 06/14/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|