Nipro Syringe

Syringe, Piston

Nipro Medical Corporation

The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Syringe.

Pre-market Notification Details

Device IDK173029
510k NumberK173029
Device Name:Nipro Syringe
ClassificationSyringe, Piston
Applicant Nipro Medical Corporation 3150 NW 107th Ave. Miami,  FL  33172
ContactJessica Oswald-mcleod
CorrespondentJessica Oswald-mcleod
Nipro Medical Corporation 3150 NW 107th Ave. Miami,  FL  33172
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-28
Decision Date2018-03-30
Summary:summary

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