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510(k) K812811

Device
MICROCOIL 80 DIALYZER
Applicant
ERIKA, INC.
510(k) number
K812811
Product code
FHS  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-03
Date received
1981-10-06
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
K811974MICROCOIL 150 DIALYZERErika, Inc.1981-09-16
K801634THE VITA 2 DISPOSABLE DIALYZERBellco Artifidial Organ Spec., Inc.1980-12-17
K800723MICRO-COIL 100 COIL DIALYZERErika, Inc.1980-05-14
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#

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FDA Review#

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