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510(k) K072174

Device
INSUCOZI INSULIN VIAL COVER
Applicant
41 INDUSTRIES LLC
510(k) number
K072174
Product code
IQG  
Decision
Substantially Equivalent (SESE)
Decision date
2008-01-25
Date received
2007-08-06
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
DANIEL LAFAVER
Address
4220 Balsam St. Wheat Ridge CO US 80033 80033

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IQG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K073555INSULIN PROTECTORMedicool, Inc.2008-07-11
K063180ISECURE SYRINGE CARTRIDGE HOLDERHospira, Inc.2006-12-11

Legacy Summary#

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FDA Review#

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