MODIFICATION TO 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 Modification To Terumo Syringe With/without Needle.

Pre-market Notification Details

Device IDK063613
510k NumberK063613
Device Name:MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
ClassificationSyringe, Piston
Applicant TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton,  MD  21921
ContactSandi Hartka
CorrespondentSandi Hartka
TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton,  MD  21921
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-05
Decision Date2006-12-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
54806017511468 K063613 000
54806017511451 K063613 000
54806017511444 K063613 000
54806017511437 K063613 000
54806017511420 K063613 000
54806017511413 K063613 000
54806017509434 K063613 000

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