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510(k) K073555

Device
INSULIN PROTECTOR
Applicant
MEDICOOL, INC.
510(k) number
K073555
Product code
IQG  
Decision
Substantially Equivalent (SESE)
Decision date
2008-07-11
Date received
2007-12-18
Regulation
890.5050
Classification name
Adaptor, Holder, Syringe
Medical specialty
Physical Medicine
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EUGENE CHANG
Address
20460 Gramercy Pl. Torrance CA US 90501 90501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IQG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K072174INSUCOZI INSULIN VIAL COVER41 Industries, LLC2008-01-25
K063180ISECURE SYRINGE CARTRIDGE HOLDERHospira, Inc.2006-12-11

Legacy Summary#

summary

FDA Review#

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