The following data is part of a premarket notification filed by Nipro Diabetes Systems, Inc. with the FDA for Glucopro Evo Infusion Pump.
| Device ID | K013309 |
| 510k Number | K013309 |
| Device Name: | GLUCOPRO EVO INFUSION PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | NIPRO DIABETES SYSTEMS, INC. 1384 COPPERFIELD COURT Lexington, KY 40514 |
| Contact | Kaelyn B Hadley |
| Correspondent | Kaelyn B Hadley NIPRO DIABETES SYSTEMS, INC. 1384 COPPERFIELD COURT Lexington, KY 40514 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-04 |
| Decision Date | 2002-06-24 |
| Summary: | summary |