TERUMO SYRINGE WITH/WITHOUT NEEDLE

Syringe, Piston

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Syringe With/without Needle.

Pre-market Notification Details

Device IDK023271
510k NumberK023271
Device Name:TERUMO SYRINGE WITH/WITHOUT NEEDLE
ClassificationSyringe, Piston
Applicant TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton,  MD  21921
ContactSandi Lartka
CorrespondentSandi Lartka
TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton,  MD  21921
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-01
Decision Date2002-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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