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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 K111858
Device Name LIFTKAR PT
Applicant
SANO TRANSPORTGERAETE GMBH
428 BELLEAIRE LANE
DOWNERS GROVE,  IL  60515
Applicant Contact JEANINE A CARROCCIO
Correspondent
SANO TRANSPORTGERAETE GMBH
428 BELLEAIRE LANE
DOWNERS GROVE,  IL  60515
Correspondent Contact JEANINE A CARROCCIO
Regulation Number890.5150
Classification Product Code
ILK  
Date Received06/30/2011
Decision Date 11/04/2011
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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