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510(k) K842513

Device
HEMOPERFUSION PROCEDURE W/REDY 2000
Applicant
ORGANON TEKNIKA CORP.
510(k) number
K842513
Product code
FKT  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-12
Date received
1984-06-26
Regulation
876.5600
Classification name
System, Dialysate Delivery, Sorbent Regenerated
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K1238352008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.2013-02-15
K0933622008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.2010-08-13
K070739ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500Renal Solutions, Inc.2007-05-25
K060381ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100Renal Solutions, Inc.2006-05-24
K043574ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000Renal Solutions, Inc.2005-06-03
K031099SORB+HISORB+CARTRIDGERenal Solutions, Inc.2003-09-17
K954623REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)Gambro Healthcare1996-08-28
K882428REDY 2000Organon Teknika Corp.1988-10-25
K874137MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CARAsh Medical Systems, Inc.1988-04-08
K870270MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.Ash Medical Systems, Inc.1987-02-25
K864179BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTRAsh Medical Systems, Inc.1986-12-11
K851188PACKETS FOR PREP. OF DIALYSATES & INFUSATES -Organon Teknika Corp.1985-04-12
K813574SORB IIOrganon Teknika Corp.1982-03-23
K812869D-3260 SORBENT CARTRIDGEOrganon Teknika Corp.1981-12-08
K811170D-3160 SORBENT CARTRIDGEOrganon Teknika Corp.1981-07-31

Legacy Summary#

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FDA Review#

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