FDA.reportPublic FDA data

510(k) K800723

Device
MICRO-COIL 100 COIL DIALYZER
Applicant
ERIKA, INC.
510(k) number
K800723
Product code
FHS  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-14
Date received
1980-04-01
Regulation
876.5820
Classification name
Dialyzer, Single Coil
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FHS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K812811MICROCOIL 80 DIALYZERErika, Inc.1981-12-03
K811974MICROCOIL 150 DIALYZERErika, Inc.1981-09-16
K801634THE VITA 2 DISPOSABLE DIALYZERBellco Artifidial Organ Spec., Inc.1980-12-17
K800174GAMBRO LUNDIA COIL DIALYZERGambro, Inc.1980-02-13
K790223DIALYZER, CD-800 COILTravenol Laboratories, S.A.1979-03-26
K781102DIALYZER, DISP., COIL, LUNDIAGambro, Inc.1978-10-17
K771349MODIFICATION TO KIDNEY DIALYZERErika, Inc.1977-08-02
K770735DIALYZER, COIL, CD, LSA, 5M1765Travenol Laboratories, S.A.1977-05-10
K761358COIL DIALYZER MODEL ALT 140Bentley Laboratories, Inc.1977-01-10
K760702ERI-FLO 900 DIALYZERErika, Inc.1976-11-19
K760374DIALYZER (MODEL 1850)Erika, Inc.1976-10-27

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