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FDA 510(k) Application Details - K080114
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K080114
Device Name
Wheelchair, Mechanical
Applicant
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
9109 COPENHAVER DRIVE
POTOMAC, MD 20854 US
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Contact
NORMAN F ESTRIN
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
01/16/2008
Decision Date
02/15/2008
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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