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FDA 510(k) Application Details - K010094
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K010094
Device Name
Wheelchair, Mechanical
Applicant
TAIWAN AN I CO.,LTD.
NO.1 BEEN TING BEEN-TSUOH
VILLAGE, SHI-KOOU SHIANG
CHIA-YI SHIANN TW
Other 510(k) Applications for this Company
Contact
ANI HWONG
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/11/2001
Decision Date
02/15/2001
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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