FDA.reportPublic FDA data

510(k) K811292

Device
PARALLEL PLATE DIALYZER HOLDER
Applicant
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
510(k) number
K811292
Product code
FKI  
Decision
Substantially Equivalent (SESE)
Decision date
1981-06-02
Date received
1981-05-11
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
K802075HOLLOW FIBER DIALYZER HOLDERRenal Devices, Inc.1980-09-16

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases