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510(k) K896817

Device
MODEL T11 FLUIDOTHERAPY UNIT
Applicant
HENLEY INTL.
510(k) number
K896817
Product code
LSB  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-18
Date received
1989-12-04
Regulation
890.5100
Classification name
Unit, Fluidotherapy
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
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 LSB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011768THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202Thermo-Electric Co.2001-08-03
K011243CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000Chattanooga Group, Inc.2001-07-06

Legacy Summary#

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FDA Review#

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