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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 K925839
Device Name TRACKMASTER
Applicant
Jas Manufacturing Co., Inc.
3228 Skylane Dr.
Carrollton,  TX  75006
Applicant Contact ERIC R DICK
Correspondent
Jas Manufacturing Co., Inc.
3228 Skylane Dr.
Carrollton,  TX  75006
Correspondent Contact ERIC R DICK
Regulation Number890.5380
Classification Product Code
IOL  
Date Received11/18/1992
Decision Date 06/24/1993
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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