MONOJECT 12ML SYRINGE

Syringe, Piston

NIPRO MEDICAL CORPORATION

The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Monoject 12ml Syringe.

Pre-market Notification Details

Device IDK130049
510k NumberK130049
Device Name:MONOJECT 12ML SYRINGE
ClassificationSyringe, Piston
Applicant NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami,  FL  33172
ContactJessica Oswald-mcleod
CorrespondentJessica Oswald-mcleod
NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami,  FL  33172
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-08
Decision Date2013-02-14
Summary:summary

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