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FDA 510(k) Application Details - K011153
Device Classification Name
Wheelchair, Powered
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510(K) Number
K011153
Device Name
Wheelchair, Powered
Applicant
GOLDEN TECHNOLOGIES, INC.
401 BRIDGE ST.
OLD FORGE, PA 18518 US
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Contact
FRED KIWAK
Other 510(k) Applications for this Contact
Regulation Number
890.3860
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Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
04/16/2001
Decision Date
05/29/2001
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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