NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

Syringe, Piston

NIPRO MEDICAL CORP.

The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Disposable Syringe With Or Without Needle.

Pre-market Notification Details

Device IDK051574
510k NumberK051574
Device Name:NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
ClassificationSyringe, Piston
Applicant NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
ContactKaelyn Hadley
CorrespondentKaelyn Hadley
NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-14
Decision Date2005-08-26
Summary:summary

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