MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)

Syringe, Piston

NIPRO MEDICAL CORPORATION

The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Monoject 60ml Syringe (luer Lock Tip, Luer Slip Tip, Catheter Tip).

Pre-market Notification Details

Device IDK131641
510k NumberK131641
Device Name:MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
ClassificationSyringe, Piston
Applicant NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Doral,  FL  33172
ContactJessica Oswald-mcleod
CorrespondentJessica Oswald-mcleod
NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Doral,  FL  33172
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-04
Decision Date2013-08-28
Summary:summary

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