The following data is part of a premarket notification filed by Nissho Corp. with the FDA for Nipro Arterial Venous Fistula Needle.
| Device ID | K955182 |
| 510k Number | K955182 |
| Device Name: | NIPRO ARTERIAL VENOUS FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | NISSHO CORP. 7205 CORPORATE CENTER DR. # 305 Miami, FL 33126 |
| Contact | Luis Candelario |
| Correspondent | Luis Candelario NISSHO CORP. 7205 CORPORATE CENTER DR. # 305 Miami, FL 33126 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-06-04 |