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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 K963817
FOIA Releasable 510(k) K963817
Device Name LEVO MOBIL LCM
Applicant
Levo USA
Bleicheweg 5
Dottikon,  CH CH-5605
Applicant Contact THOMAS RAEBER
Correspondent
Levo USA
Bleicheweg 5
Dottikon,  CH CH-5605
Correspondent Contact THOMAS RAEBER
Regulation Number890.3900
Classification Product Code
IPL  
Date Received09/23/1996
Decision Date 12/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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