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510(k) K843504

Device
AMER. BENTLEY HEMOFILTER HOLDER HFH-1
Applicant
AMERICAN BENTLEY
510(k) number
K843504
Product code
FKI  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-18
Date received
1984-09-06
Regulation
876.5820
Classification name
Set, Dialyzer Holder
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DONALD A RAIBLE
Address
17502 Armstrong Ave. Irvine CA US 92714 92714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K811292PARALLEL PLATE DIALYZER HOLDERExtracorporeal Medical Specialities, Inc.1981-06-02
K802075HOLLOW FIBER DIALYZER HOLDERRenal Devices, Inc.1980-09-16

Legacy Summary#

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FDA Review#

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