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510(k) K911349

Device
E-Z-EM ENTEROCLYSIS CATHETER SET
Applicant
E-Z-EM, INC.
510(k) number
K911349
Product code
EZK  
Decision
Substantially Equivalent (SESE)
Decision date
1992-11-16
Date received
1991-03-27
Regulation
876.5980
Classification name
Catheter, Retention Type
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MERRIBETH ADAMS
Address
717 Main St. Westbury NY US 11590 11590

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EZK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K903816URINE METER FOLEY TRAY WITH TEMPERATURE SENSORRespiratory Support Products, Inc.1990-10-31
K770408KARAYA GUM POWDER, OSTOMYHowmedica Corp.1977-03-15

Legacy Summary#

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FDA Review#

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