The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Disposable Syringe With Or Without Needle.
| Device ID | K051574 |
| 510k Number | K051574 |
| Device Name: | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE |
| Classification | Syringe, Piston |
| Applicant | NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Contact | Kaelyn Hadley |
| Correspondent | Kaelyn Hadley NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-14 |
| Decision Date | 2005-08-26 |
| Summary: | summary |