NIPRO HYPODERMIC NEEDLE

Needle, Hypodermic, Single Lumen

NIPRO MEDICAL CORP.

The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Hypodermic Needle.

Pre-market Notification Details

Device IDK013293
510k NumberK013293
Device Name:NIPRO HYPODERMIC NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
ContactKaelyn B Hadley
CorrespondentKaelyn B Hadley
NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-02
Decision Date2001-12-14
Summary:summary

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