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510(k) K900419

Device
CRYOTRON-UL30
Applicant
HENLEY INTL.
510(k) number
K900419
Product code
IMF  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-27
Date received
1990-01-30
Regulation
890.5940
Classification name
Unit, Chilling
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ERNEST J HENLEY,PHD
Address
104 Industrial Blvd., Sugar Land TX US 77470 77470

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IMF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871112PELTIERTHERAPY(C) HEAT/COLD TREATMENTHenley Intl.1987-05-06

Legacy Summary#

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FDA Review#

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