Dana 3CC Syringe Insulin Reservoir

FDA 510(k) K071418 · Sooil Development Co., Ltd.

Substantially Equivalent

510(k) numberK071418

Submission

Device name
Dana 3CC Syringe Insulin Reservoir
Applicant
Sooil Development Co., Ltd.
North Attleboro, MA, US
Received
May 22, 2007
Decision date
September 4, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRZ – Accessories, Pump, Infusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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Questions and answers

When was Dana 3CC Syringe Insulin Reservoir cleared by the FDA?

Dana 3CC Syringe Insulin Reservoir (K071418) received a 510(k) decision of Substantially Equivalent on September 4, 2007, 105 days after the submission was received.

What is the product code of K071418?

The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.