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 |