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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 K760509
Device Name TREADMILL, DIAGNOSTIC
Applicant
Medcraft Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medcraft Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5380
Classification Product Code
IOL  
Date Received08/24/1976
Decision Date 08/30/1976
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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