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510(k) K840424

Device
HEMOCATH REPAIR KIT
Applicant
QUINTON, INC.
510(k) number
K840424
Product code
KNZ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-05
Date received
1984-02-01
Regulation
876.5540
Classification name
Accessories, A-v Shunt
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KNZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842039ARGON DUAL LUMEN HEMODIALYSIS, CATHETERArgon Medical Corp.1985-01-29
K844612ACUTE HEMODIALYSIS TRAYSPackaging Technologies, Inc.1984-12-17
K842864VACCESS FEMORAL CANNULAVas-Cath of Canada , Ltd.1984-08-08
K842416DUO FLOW CATHETER-MC 54Medical Components, Inc.1984-07-26
K841530DOUBLE LUMEN SUBLCAVIAN-FEMORALMedical Components, Inc.1984-06-25
K841119TOPS DISPOS. INFUSION SET/HEMODIALYSISTop Surgical Manufacturers Co.1984-04-20
K840437HEMASITE ACCESSORIES MODIFICATIONRenal Systems, Inc.1984-02-21
K834510RENAFLO AVF SET FOR HEMODIALYSISRenal Systems, Inc.1984-02-04
K833139ACUTE HEMODIALYSIS TRAYSIntermed, Inc.1983-12-22

Legacy Summary#

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FDA Review#

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