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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Disposable
510(k) Number K844224
Device Name EIXO THERMUS HEATING PADS
Applicant
Eixo Thermus
2220 Gustavus St.
Laredo,  TX  78043
Applicant Contact LAWRENCE FRIEDMAN
Correspondent
Eixo Thermus
2220 Gustavus St.
Laredo,  TX  78043
Correspondent Contact LAWRENCE FRIEDMAN
Regulation Number890.5710
Classification Product Code
IMD  
Date Received11/01/1984
Decision Date 11/23/1984
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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