Isecure Syringe Cartridge Holder

FDA 510(k) K063180 · Hospira, Inc.

Substantially Equivalent

510(k) numberK063180

Submission

Device name
Isecure Syringe Cartridge Holder
Applicant
Hospira, Inc.
Lake Forest, IL, US
Received
October 19, 2006
Decision date
December 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IQG – Adaptor, Holder, Syringe
Device class
Class I (low risk)
Regulation
21 CFR 890.5050
Specialty
Physical Medicine

Other 510(k)s with product code IQG

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K073555Insulin ProtectorIQG · Traditional Medicool, Inc.07/11/2008SE
K072174Insucozi Insulin Vial CoverIQG · Traditional 41 Industries, LLC01/25/2008SE

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Questions and answers

When was Isecure Syringe Cartridge Holder cleared by the FDA?

Isecure Syringe Cartridge Holder (K063180) received a 510(k) decision of Substantially Equivalent on December 11, 2006, 53 days after the submission was received.

What is the product code of K063180?

The FDA product code is IQG – Adaptor, Holder, Syringe, a Class I (low risk) device regulated under 21 CFR 890.5050.