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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
Recalls CDRH Recalls
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