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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 K890793
Device Name STARTRAC
Applicant
Unisen, Inc.
14352 Chambers Rd.
Tustin,  CA  92680
Applicant Contact JIM PITTAWAY
Correspondent
Unisen, Inc.
14352 Chambers Rd.
Tustin,  CA  92680
Correspondent Contact JIM PITTAWAY
Regulation Number890.5380
Classification Product Code
IOL  
Date Received02/17/1989
Decision Date 03/16/1989
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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