Insulin Protector

FDA 510(k) K073555 · Medicool, Inc.

Substantially Equivalent

510(k) numberK073555

Submission

Device name
Insulin Protector
Applicant
Medicool, Inc.
Torrance, CA, US
Received
December 18, 2007
Decision date
July 11, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

510(k)DeviceApplicantDecision
K072174Insucozi Insulin Vial CoverIQG · Traditional 41 Industries, LLC01/25/2008SE
K063180Isecure Syringe Cartridge HolderIQG · Special Hospira, Inc.12/11/2006SE

More from Hospira, Inc.

510(k)DeviceDecision
K895674Medicool, Container for Storing InsulinLDQ · Traditional 01/11/1990SE

Questions and answers

When was Insulin Protector cleared by the FDA?

Insulin Protector (K073555) received a 510(k) decision of Substantially Equivalent on July 11, 2008, 206 days after the submission was received.

What is the product code of K073555?

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