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510(k) K925469

Device
JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
Applicant
J.J. SKINNER, INC.
510(k) number
K925469
Product code
FKG  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-03
Date received
1992-10-29
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
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROLANN KOTULA-COOK
Address
C/O Medical Device Inspection 55 Northern Blvd., Suite 301 Great Neck NY US 11021 11021

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
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
K792207PERIDIAL PERITONEAL DIALYSIS TRAYCutter Laboratories, Inc.1979-12-10
K790353ACUTE RENAL DIALYSIS TRAYArgon Medical Corp.1979-04-20

Legacy Summary#

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FDA Review#

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