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FDA 510(k) Application Details - K032101
Device Classification Name
Wheelchair, Standup
More FDA Info for this Device
510(K) Number
K032101
Device Name
Wheelchair, Standup
Applicant
THE STANDING CO., INC.
1916 S. NIAGARA ST., SUITE A
SAGINAW, MI 48602 US
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Contact
MICHAEL A OLVERA
Other 510(k) Applications for this Contact
Regulation Number
890.3900
More FDA Info for this Regulation Number
Classification Product Code
IPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/2003
Decision Date
01/22/2004
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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