The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Arterial Venous Fistula Needle, Agulha Para Fistula Arterio-venosa, Aguja Para Fistula Arterio Venosa.
| Device ID | K991623 |
| 510k Number | K991623 |
| Device Name: | NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA |
| Classification | Needle, Fistula |
| 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 | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-11 |
| Decision Date | 1999-08-09 |
| Summary: | summary |