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FDA 510(k) Application Details - K094047
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K094047
Device Name
Wheelchair, Mechanical
Applicant
MODERN REHABILITATION SOLUTIONS CO., LTD
5401 S COTTONWOOD CT
GREENWOOD VILLAGE, CO 80121 US
Other 510(k) Applications for this Company
Contact
Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2009
Decision Date
03/22/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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