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510(k) K861586

Device
LOPEZ VALVE
Applicant
ICU MEDICAL, INC.
510(k) number
K861586
Product code
MJF  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-18
Date received
1986-04-29
Regulation
880.5440
Classification name
Check Valve, Retrograde Flow (in-line)
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEORGE A LOPEZ
Address
5200 Warner Ave., Suite 108 Huntington Beach CA US 92649 92649

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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