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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K061912
Device Name FUSION
Applicant
Burke, Inc.
1800 Merriam Ln.
Kansas City,  KS  66106
Applicant Contact DUWAYNE E KRAMER, JR.
Correspondent
Burke, Inc.
1800 Merriam Ln.
Kansas City,  KS  66106
Correspondent Contact DUWAYNE E KRAMER, JR.
Regulation Number890.3800
Classification Product Code
INI  
Date Received07/06/2006
Decision Date 08/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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