TERUMO DISPOSABLE HYPODERMC SYRINGE

Syringe, Piston

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Disposable Hypodermc Syringe.

Pre-market Notification Details

Device IDK980181
510k NumberK980181
Device Name:TERUMO DISPOSABLE HYPODERMC SYRINGE
ClassificationSyringe, Piston
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactKristine Wagner
CorrespondentKristine Wagner
TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-20
Decision Date1998-04-02
Summary:summary

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