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510(k) K991005

Device
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS
Applicant
DAYSPRING MEDICAL, INC.
510(k) number
K991005
Product code
LLB  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-22
Date received
1999-03-25
Regulation
876.5820
Classification name
System, Blood, Extracorporeal And Accessories
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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831404BLOOD MONITOR BMM 10-4Gambro, Inc.1984-04-25

Legacy Summary#

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FDA Review#

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