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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K083017
Device Name LEVO C3
Applicant
Levo AG
Anglikerstrasse 20
5610 Wohlen,  CH CH-5610
Applicant Contact THOMAS RABER
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number890.3900
Classification Product Code
IPL  
Date Received10/09/2008
Decision Date 10/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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