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510(k) K810021

Device
FLO-TEMP
Applicant
LAMINAR FLOW INDUSTRIES
510(k) number
K810021
Product code
FLA  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-23
Date received
1981-01-05
Regulation
876.5820
Classification name
Monitor, Temperature, Dialysis
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
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 FLA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140623NXSTAGE EXPRESS FLUID WARMERNxstage Medical, Inc.2014-06-16
K842302FLUID WARMEROrganon Teknika Corp.1984-08-27

Legacy Summary#

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FDA Review#

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