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510(k) K063180

Device
ISECURE SYRINGE CARTRIDGE HOLDER
Applicant
HOSPIRA, INC.
510(k) number
K063180
Product code
IQG  
Decision
Substantially Equivalent (SESE)
Decision date
2006-12-11
Date received
2006-10-19
Regulation
890.5050
Classification name
Adaptor, Holder, Syringe
Medical specialty
Physical Medicine
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DIANE RENNPFERD
Address
275 N. Field Dr., Bldg. H-2 Dept. 389 Lake Forest IL US 60045 60045

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
K073555INSULIN PROTECTORMedicool, Inc.2008-07-11
K072174INSUCOZI INSULIN VIAL COVER41 Industries, LLC2008-01-25

Legacy Summary#

summary

FDA Review#

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