NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET

Protector, Transducer, Dialysis

NIPRO MEDICAL CORP.

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.

Pre-market Notification Details

Device IDK001465
510k NumberK001465
Device Name:NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
ClassificationProtector, Transducer, Dialysis
Applicant NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston,  FL  33326
ContactRichard D Bliss, Jr.
CorrespondentRichard D Bliss, Jr.
NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston,  FL  33326
Product CodeFIB  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-10
Decision Date2000-12-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.