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FDA 510(k) Application Details - K011701
Device Classification Name
Wheelchair, Mechanical
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510(K) Number
K011701
Device Name
Wheelchair, Mechanical
Applicant
TAIWAN ARMADA ENTERPRISE CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY TW
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Contact
JEN KE-MIN
Other 510(k) Applications for this Contact
Regulation Number
890.3850
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Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
06/01/2001
Decision Date
06/22/2001
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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