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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 K871179
Device Name OPN XII UL
Applicant
Aragona AB Co.
Box 6018
102 31 Stockholm
Sweden,  SE
Applicant Contact PETER ROGEMAN
Correspondent
Aragona AB Co.
Box 6018
102 31 Stockholm
Sweden,  SE
Correspondent Contact PETER ROGEMAN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received03/24/1987
Decision Date 04/13/1987
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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