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510(k) K991003

Device
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI
Applicant
DAYSPRING MEDICAL, INC.
510(k) number
K991003
Product code
FKY  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-09
Date received
1999-03-25
Regulation
876.5820
Classification name
Connector, Tubing, Dialysate
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NEIL RASMUSSEN
Address
1936 Beacon Ct. Boulder CO US 80302 80302

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862722TUBING CONNECTOR #10-810-60 100/PKG NON-STERILEMercury Enterprises, Inc.1986-08-11
K830002CAPD COLOR-GUARD SYSTEM PREPKITAbbott Laboratories1983-03-11
K771428TENCKHOFF PERITONEAL TUBING ADAPT.Quinton, Inc.1977-10-18

Legacy Summary#

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FDA Review#

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