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FDA 510(k) Application Details - K063020
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K063020
Device Name
Plate, Fixation, Bone
Applicant
INTAI TECHNOLOGY INC.
4230 EAST AIRPORT DRIVE
SUITE 110
ONTARIO, CA 91761 US
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Contact
PIEWEN LIN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
10/02/2006
Decision Date
12/14/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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