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FDA 510(k) Application Details - K043511
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K043511
Device Name
Wheelchair, Powered
Applicant
SOLEUS CHAMP INTERNATIONAL CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY 300 TW
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Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
12/20/2004
Decision Date
03/14/2005
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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