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510(k) K792207

Device
PERIDIAL PERITONEAL DIALYSIS TRAY
Applicant
CUTTER LABORATORIES, INC.
510(k) number
K792207
Product code
FKG  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-10
Date received
1979-11-02
Regulation
876.5820
Classification name
Tray, Start/stop (including Contents), Dialysis
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
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 FKG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925469JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KITJ.J. Skinner, Inc.1995-05-03
K871630KITS AND TRAYS FOR DIALYSIS USEDove Medical Supplies1987-05-26
K833780CAPD PREP KITProfessional Dialysis Products1984-02-09
K802361DIALYIS START CARE KITMed-Pak Corp.1981-01-16
K790353ACUTE RENAL DIALYSIS TRAYArgon Medical Corp.1979-04-20

Legacy Summary#

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FDA Review#

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