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FDA 510(k) Application Details - K051302
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K051302
Device Name
Wheelchair, Mechanical
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact
LARA N SIMMONS
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
05/19/2005
Decision Date
08/15/2005
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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