The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Blood Tubing Set With Transducer And Solution Set For Hemodialysis.
| Device ID | K972206 |
| 510k Number | K972206 |
| Device Name: | NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| 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 | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-11 |
| Decision Date | 1997-11-26 |
| Summary: | summary |