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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 K770240
Device Name TREADMILL STRESS EXERCISE SYSTEM
Applicant
Burdick Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Burdick Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5380
Classification Product Code
IOL  
Date Received02/07/1977
Decision Date 02/14/1977
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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