The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Transducer Protector Tp-sure, Model Tpsure+1.
| Device ID | K072988 |
| 510k Number | K072988 |
| Device Name: | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 |
| Classification | Protector, Transducer, Dialysis |
| 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 | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-23 |
| Decision Date | 2008-02-21 |
| Summary: | summary |