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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K090350
Device Name EXTREME 4X4-X8 POWER WHEELCHAIR
Applicant
Vestil Manufacturing Corp.
201 Growth Pkwy.
Angola,  IN  46703
Applicant Contact RICK MICHAEL
Correspondent
Vestil Manufacturing Corp.
201 Growth Pkwy.
Angola,  IN  46703
Correspondent Contact RICK MICHAEL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/11/2009
Decision Date 04/10/2009
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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