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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 K895104
Device Name AQUATREX UNDERWATER TREADMILL SYSTEM
Applicant
Edmonds Medical Systems
7711 230th SW
Edmonds,  WA  98020
Applicant Contact ROGER KELLER
Correspondent
Edmonds Medical Systems
7711 230th SW
Edmonds,  WA  98020
Correspondent Contact ROGER KELLER
Regulation Number890.5380
Classification Product Code
IOL  
Date Received08/15/1989
Decision Date 12/04/1989
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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