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FDA 510(k) Application Details - K050280
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K050280
Device Name
Wheelchair, Mechanical
Applicant
ACCESS POINT MEDICAL, L.L.C.
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
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Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
02/07/2005
Decision Date
04/11/2005
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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