The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Monoject Insulin Syringe.
| Device ID | K991758 |
| 510k Number | K991758 |
| Device Name: | MONOJECT INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-24 |
| Decision Date | 1999-06-14 |
| Summary: | summary |