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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K021866
Device Name KARMA 800 SERIES MANUAL WHEELCHAIR
Applicant
Vestil Manufacturing Corp.
900 Growth Pkwy.
Angola,  IN  46703
Applicant Contact RICK MICHAEL
Correspondent
Vestil Manufacturing Corp.
900 Growth Pkwy.
Angola,  IN  46703
Correspondent Contact RICK MICHAEL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/06/2002
Decision Date 06/14/2002
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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