The following data is part of a premarket notification filed by Pharmaseal Div., Baxter Healthcare Corp. with the FDA for Low Dead Space Insulin Syringe.
| Device ID | K790409 |
| 510k Number | K790409 |
| Device Name: | LOW DEAD SPACE INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | PHARMASEAL DIV., BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-26 |
| Decision Date | 1979-04-24 |