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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Heating, Powered
510(k) Number K950350
Device Name THEMALATOR. MODELS T-4-S, T-8-S, ETC.
Applicant
Whitehall/Div Columbus Mckennon Corp.
15058 Proctor Ave.
P.O. Box 3527
City Of Industry,  CA  91744
Applicant Contact RICHARD E UHLIG
Correspondent
Whitehall/Div Columbus Mckennon Corp.
15058 Proctor Ave.
P.O. Box 3527
City Of Industry,  CA  91744
Correspondent Contact RICHARD E UHLIG
Regulation Number890.5950
Classification Product Code
IRQ  
Subsequent Product Code
IMA  
Date Received01/30/1995
Decision Date 03/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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