NIPRO DISPOSABLE SYRINGES

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 Syringes.

Pre-market Notification Details

Device IDK030683
510k NumberK030683
Device Name:NIPRO DISPOSABLE SYRINGES
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-05
Decision Date2003-10-31
Summary:summary

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