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FDA 510(k) Application Details - K083231
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K083231
Device Name
Wheelchair, Mechanical
Applicant
PANTHERA PRODUCTION AB
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN, TX 78746 US
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Contact
STUART R GOLDMAN
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
11/03/2008
Decision Date
01/26/2009
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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