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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 K861340
Device Name R1750 AND R1424 POWERED HEATING UNITS
Applicant
Tri W-G, Inc.
P.O. Box 905
Valley City,  ND  58072
Applicant Contact JOHN WEBER
Correspondent
Tri W-G, Inc.
P.O. Box 905
Valley City,  ND  58072
Correspondent Contact JOHN WEBER
Regulation Number890.5950
Classification Product Code
IRQ  
Date Received04/07/1986
Decision Date 05/02/1986
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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