MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE

Syringe, Piston

TYCO HEALTHCARE

The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Monoject Magellan Insulin And Tuberculin Safety Syringe.

Pre-market Notification Details

Device IDK061492
510k NumberK061492
Device Name:MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
ClassificationSyringe, Piston
Applicant TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactMichelle Kelley
CorrespondentMichelle Kelley
TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-31
Decision Date2006-08-03
Summary:summary

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