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510(k) K903816

Device
URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
Applicant
RESPIRATORY SUPPORT PRODUCTS, INC.
510(k) number
K903816
Product code
EZK  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1990-10-31
Date received
1990-08-20
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
KERRY J TOMIC
Address
2552 Mcgaw Ave. Irvine CA US 92614 92614

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
K911349E-Z-EM ENTEROCLYSIS CATHETER SETE-Z-Em, Inc.1992-11-16
K770408KARAYA GUM POWDER, OSTOMYHowmedica Corp.1977-03-15

Legacy Summary#

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FDA Review#

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