The following data is part of a premarket notification filed by Nipro Diabetes Systems, Inc. with the FDA for Glucopro Syringe, Model Gpsy-xxxxxxxx.
| Device ID | K014114 |
| 510k Number | K014114 |
| Device Name: | GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX |
| Classification | Syringe, Piston |
| 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 | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-14 |
| Decision Date | 2002-06-26 |
| Summary: | summary |