The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Blood Tubing Set With Transducer Protector And Priming Set.
| Device ID | K112628 |
| 510k Number | K112628 |
| Device Name: | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2012-09-28 |
| Summary: | summary |