FDA.reportPublic FDA data

510(k) K760922

Device
Perfusion Tubing Set
Applicant
SHILEY, INC.
510(k) number
K760922
Product code
KDL
Decision
Substantially Equivalent (SESE)
Decision date
1976-11-19
Date received
1976-10-28
Regulation
876.5880
Classification name
Set, Perfusion, Kidney, Disposable
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

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K043461CUSTODIOLDr. Franz Kohler Chemie GmbH2005-02-28
K020924CUSTODIOL HTK SOLUTIONDr. Franz Kohler Chemie GmbH2003-01-06
K955497GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SETCobe Renal Care, Inc.1997-09-25
K944866VIASPAN (BELZER UW - CSS)The Dupont Merck Pharmaceutical Co.1996-04-22
K900492LABELING CHANGE - VIASPAN(TM) (BELZER UW)The DU Pont Co.1990-03-20
K891239MOP CATHETERBivona Medical Technologies1989-11-28