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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 K800251
Device Name MT-10, ET-20
Applicant
Associated Mills, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Associated Mills, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5370
Classification Product Code
IOG  
Date Received02/06/1980
Decision Date 04/02/1980
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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