The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Insulin Syringe.
| Device ID | K000144 |
| 510k Number | K000144 |
| Device Name: | NIPRO INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | NIPRO MEDICAL CORP. 3150 NW 107 AVE.. Miami, FL 33172 |
| Contact | Gary Goldsmith |
| Correspondent | Gary Goldsmith NIPRO MEDICAL CORP. 3150 NW 107 AVE.. Miami, FL 33172 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-02-11 |