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510(k) K950350

Device
THEMALATOR. MODELS T-4-S, T-8-S, ETC.
Applicant
WHITEHALL/DIV COLUMBUS MCKENNON CORP.
510(k) number
K950350
Product code
IRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-24
Date received
1995-01-30
Regulation
890.5950
Classification name
Unit, Heating, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD E UHLIG
Address
15058 Proctor Ave. P.O. Box 3527 City Of Industry CA US 91744 91744

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050524EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000Marda Medical, Inc.2005-09-14
K924023FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917Ferno1993-04-14
K880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)Fred Sammons, Inc.1988-05-06
K861340R1750 AND R1424 POWERED HEATING UNITSTri W-G, Inc.1986-05-02
K832177PULSAIR MODEL SP-1Thermowave Medical Device Corp.1983-12-09
K801625THERMOLATOR HEATING UNITTru-Eze Mfg. Co., Inc.1980-07-28

Legacy Summary#

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FDA Review#

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