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FDA 510(k) Application Details - K050290
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K050290
Device Name
Wheelchair, Mechanical
Applicant
LERADO OVERSEA LTD. TWN BRANCH (BVI)
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY 30067 TW
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Contact
JEN KE-MIN
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
02/07/2005
Decision Date
02/18/2005
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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