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FDA 510(k) Application Details - K063708
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K063708
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
TAE YEON MEDICAL CO., LTD
204, NAMDONG INDUSTRIAL
COMPLEX, 45B-6L,# 435-6, N
INCHEON 405-848 KR
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Contact
GIL WOON CHOI
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
12/13/2006
Decision Date
04/24/2007
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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