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FDA 510(k) Application Details - K132644
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K132644
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
CORENTEC CO., LTD
8TH FLOOR CHUNGHO TOWER
748-1 BANPO 1 DONG
SEOCHO GU, SEOUL 137-040 KR
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Contact
J.S. DANIEL
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
08/26/2013
Decision Date
09/19/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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