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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport, Patient, Powered
510(k) Number K121560
Device Name LEVANT, HOMEGLIDE
Applicant
Thyssenkrupp Accessibility B.V.
Van Utrechtweg 99
Krimpen Aan Den Ijssel
Zuid-Holland,  NL 2921 LN
Applicant Contact ARNOLD HEIDEN
Correspondent
Thyssenkrupp Accessibility B.V.
Van Utrechtweg 99
Krimpen Aan Den Ijssel
Zuid-Holland,  NL 2921 LN
Correspondent Contact ARNOLD HEIDEN
Regulation Number890.5150
Classification Product Code
ILK  
Date Received05/29/2012
Decision Date 11/01/2012
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
Recalls CDRH Recalls
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