The following data is part of a premarket notification filed by Nissho Corp. with the FDA for Nipro Arterial & Venous Blood Tubing Set For Hemodialysis.
| Device ID | K954676 |
| 510k Number | K954676 |
| Device Name: | NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | NISSHO CORP. 7205 CORPORATE CENTER DR. # 305 Miami, FL 33126 |
| Contact | Kaelyn Hadley |
| Correspondent | Kaelyn Hadley NISSHO CORP. 7205 CORPORATE CENTER DR. # 305 Miami, FL 33126 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1997-03-04 |
| Summary: | summary |