GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX

Syringe, Piston

NIPRO DIABETES SYSTEMS, INC.

The following data is part of a premarket notification filed by Nipro Diabetes Systems, Inc. with the FDA for Glucopro Syringe, Model Gpsy-xxxxxxxx.

Pre-market Notification Details

Device IDK014114
510k NumberK014114
Device Name:GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
ClassificationSyringe, Piston
Applicant NIPRO DIABETES SYSTEMS, INC. 1384 COPPERFIELD COURT Lexington,  KY  40514
ContactKaelyn B Hadley
CorrespondentKaelyn B Hadley
NIPRO DIABETES SYSTEMS, INC. 1384 COPPERFIELD COURT Lexington,  KY  40514
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-14
Decision Date2002-06-26
Summary:summary

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