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FDA 510(k) Application Details - K111858
Device Classification Name
Transport, Patient, Powered
More FDA Info for this Device
510(K) Number
K111858
Device Name
Transport, Patient, Powered
Applicant
SANO TRANSPORTGERAETE GMBH
428 BELLEAIRE LANE
DOWNERS GROVE, IL 60515 US
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Contact
JEANINE A CARROCCIO
Other 510(k) Applications for this Contact
Regulation Number
890.5150
More FDA Info for this Regulation Number
Classification Product Code
ILK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2011
Decision Date
11/04/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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