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510(k) K022068

Device
TUBING, DIALYSATE (AND CONNECTOR)
Applicant
MOLDED PRODUCTS INC.
510(k) number
K022068
Product code
FID  
Decision
Substantially Equivalent (SESE)
Decision date
2002-09-23
Date received
2002-06-25
Regulation
876.5820
Classification name
Tubing, Dialysate
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
ELISE JOHNSTON
Address
601 Durant St. Harlan IA US 51537 51537

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010712DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINESMolded Products, Inc.2001-09-27
K770299TYGON M-60/TYGON M-70Norton Performance Plastics Corp.1977-03-16

Legacy Summary#

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FDA Review#

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