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510(k) K802075

Device
HOLLOW FIBER DIALYZER HOLDER
Applicant
RENAL DEVICES, INC.
510(k) number
K802075
Product code
FKI  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-16
Date received
1980-08-27
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#

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 FKI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843504AMER. BENTLEY HEMOFILTER HOLDER HFH-1American Bentley1984-10-18
K811292PARALLEL PLATE DIALYZER HOLDERExtracorporeal Medical Specialities, Inc.1981-06-02

Legacy Summary#

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FDA Review#

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