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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K101267
Device Name PREMIO 10 MOXA
Applicant
Sedatelec
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact Kevin Walls
Correspondent
Sedatelec
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/05/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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