1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES

Syringe, Antistick

INVIRO MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Inviro Medical Devices, Inc. with the FDA for 1 Ml Fixed Needle, 3 Ml Luer Lock, 5 Ml Luer Lock, 10 Ml Luer Lock, 20 Ml Luerl Lock Safety Syringes.

Pre-market Notification Details

Device IDK092430
510k NumberK092430
Device Name:1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
ClassificationSyringe, Antistick
Applicant INVIRO MEDICAL DEVICES, INC. 1755 NORTH BROWN ROAD SUITE 150 Lawrenceville,  GA  30043
ContactJim Barley
CorrespondentJim Barley
INVIRO MEDICAL DEVICES, INC. 1755 NORTH BROWN ROAD SUITE 150 Lawrenceville,  GA  30043
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-07
Decision Date2009-09-04
Summary:summary
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