The following data is part of a premarket notification filed by Allison Medical, Inc. with the FDA for Allison Medical Insulin Syringe (amis).
| Device ID | K984017 |
| 510k Number | K984017 |
| Device Name: | ALLISON MEDICAL INSULIN SYRINGE (AMIS) |
| Classification | Syringe, Piston |
| Applicant | ALLISON MEDICAL, INC. 4301 SOUTH FEDERAL BLVD., SUITE 116 Englewood, CO 80110 |
| Contact | Justin Ferrin |
| Correspondent | Justin Ferrin ALLISON MEDICAL, INC. 4301 SOUTH FEDERAL BLVD., SUITE 116 Englewood, CO 80110 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-12 |
| Decision Date | 1999-03-04 |