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FDA 510(k) Application Details - K082857
Device Classification Name
Wheelchair, Special Grade
More FDA Info for this Device
510(K) Number
K082857
Device Name
Wheelchair, Special Grade
Applicant
ALPHA ONE
5600 WISCONSIN AVE
SUITE 509
CHEVY CHASE, MD 20815 US
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Contact
PATSY J TRISLER
Other 510(k) Applications for this Contact
Regulation Number
890.3880
More FDA Info for this Regulation Number
Classification Product Code
IQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2008
Decision Date
01/06/2009
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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