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510(k) K871112

Device
PELTIERTHERAPY(C) HEAT/COLD TREATMENT
Applicant
HENLEY INTL.
510(k) number
K871112
Product code
IMF  
Decision
Substantially Equivalent (SESE)
Decision date
1987-05-06
Date received
1987-03-19
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
Address
10518 Kinghurst Houston TX US 77099 77099

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
K900419CRYOTRON-UL30Henley Intl.1990-02-27

Legacy Summary#

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FDA Review#

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