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FDA 510(k) Application Details - K083044
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K083044
Device Name
Wheelchair, Mechanical
Applicant
SHANGHAI HUBANG MEDICAL APPLIANCES CO., LTD.
14F-2, NO.1, LANE 25
ZHUANGJING RD.
BANQIAO 220 TW
Other 510(k) Applications for this Company
Contact
JUNNATA CHANG
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
10/14/2008
Decision Date
12/12/2008
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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