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510(k) K914530

Device
ICAN GT DRAINAGE BAG
Applicant
ICN PHARMACEUTICALS, INC.
510(k) number
K914530
Product code
FRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-18
Date received
1991-10-11
Regulation
876.5980
Classification name
Tube, Levine
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN J GOLDNER
Address
Icn Plz. 3300 Hyland Ave. Costa Mesa CA US 92626 92626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914887ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCTMallinckrodt Medical1992-05-08
K802007PEDIWET=GUAZE IMPREGNATED WITH PETROLPollak (Intl.), Ltd.1980-09-26

Legacy Summary#

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FDA Review#

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