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510(k) K834455

Device
MONOXYCHLOROSENE WAREXIN
Applicant
GUARDIAN CHEMICAL
510(k) number
K834455
Product code
FKQ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-07-31
Date received
1983-12-19
Regulation
876.5820
Classification name
System, Dialysate Delivery, Central Multiple Patient
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbH2006-06-09
K893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.1989-07-24
K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.1988-04-27
K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.1987-10-09
K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific Industries1987-07-08
K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.1987-06-09
K864635FOUR TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.1987-01-13
K862304DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEMCd Medical, Inc.1986-09-09
K861472MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445National Medical Care, Medical Products Div., Inc.1986-07-10
K852359AMUCHINA/DIALYZER DISINFECTANTAmuchina Intl., Inc.1986-05-13
K860296HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVESPhysicians Surgeons Purchasing Group1986-03-04
K860297HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVESRenal Hygienics1986-03-04
K860336HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTSBreem Laboratories1986-03-04
K854391HEMODIALYSIS CONCENTRATEDana Laboratories1986-01-08
K852749RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANTMesa Medical, Inc.1985-09-10

Legacy Summary#

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FDA Review#

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