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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K885095
Device Name SUPREME TONING SYSTEMS
Applicant
Supreme Toning Systems
509 Maple
Coffeyville,  KS  67337
Applicant Contact CLARKE BUMGARNER,DC
Correspondent
Supreme Toning Systems
509 Maple
Coffeyville,  KS  67337
Correspondent Contact CLARKE BUMGARNER,DC
Regulation Number890.5380
Classification Product Code
BXB  
Date Received12/09/1988
Decision Date 02/06/1989
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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