The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Blood Tubing Set For Hemodialysis With Transducer Protectors And Priming Set.
| Device ID | K010264 |
| 510k Number | K010264 |
| Device Name: | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET |
| Classification | Protector, Transducer, Dialysis |
| Applicant | NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston, FL 33326 |
| Contact | Richard D Bliss, Jr |
| Correspondent | Richard D Bliss, Jr NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston, FL 33326 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-04-27 |