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510(k) K812311

Device
CIRCULATING CYTO-THERMS
Applicant
CRYOSAN, INC.
510(k) number
K812311
Product code
KZL  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-16
Date received
1981-08-17
Regulation
864.9205
Classification name
Device, Warming. Blood And Plasma
Medical specialty
Hematology
Review panel
Hematology
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 KZL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K813489ROCKING/CIRCULATING CYTO-THERM II 3570Cryosan, Inc.1982-03-04
K800699FLO TEM (FLUID WARNER)Chroma Products, Inc.1980-05-08
K790936MODEL 114 TREONIC H150 HAEMOHEATERVickers America Medical Corp.1979-09-04

Legacy Summary#

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FDA Review#

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