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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Treadmill, Powered
510(k) Number K851630
Device Name TMX-80 TREADMILL
Applicant
Eaton Medical Group
P.O. Box 276
Eaton,  MI 
Applicant Contact PAUL P KLUWE
Correspondent
Eaton Medical Group
P.O. Box 276
Eaton,  MI 
Correspondent Contact PAUL P KLUWE
Regulation Number890.5380
Classification Product Code
IOL  
Date Received04/18/1985
Decision Date 07/09/1985
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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