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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Treadmill, Mechanical
510(k) Number K801250
Device Name HYDRA TRED DC
Applicant
MEDICHANICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICHANICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.5370
Classification Product Code
IOG  
Date Received05/28/1980
Decision Date 06/17/1980
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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