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510(k) K855001

Device
FRESENIUS HEMODIALYSIS MACHINE A1008 BSM
Applicant
SERATRONICS, INC.
510(k) number
K855001
Product code
FLC  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-21
Date received
1985-12-13
Regulation
876.5820
Classification name
Station, Dialysis Control, Negative Pressure Type
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BEN J LIPPS
Address
4090 Pike Ln. Concord CA US 94520 94520

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FLC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K910656WILSON-COOK DISPOSABLE BIOPSY FORCEPSWilson-Cook Medical, Inc.1991-04-25
K791164NEGATOVE PRESSURE CONVERTORMedicorp, Inc.1979-10-04
K760725COIL MACHINE ADAPTERGambro, Inc.1976-10-27

Legacy Summary#

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FDA Review#

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