MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

TYCO HEALTHCARE

The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Monoject Prefill Heparin Lock Flush Syringe.

Pre-market Notification Details

Device IDK013556
510k NumberK013556
Device Name:MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactDavid A Olson
CorrespondentDavid A Olson
TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-25
Decision Date2001-12-31
Summary:summary

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