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FDA 510(k) Application Details - K072436
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K072436
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
BK MEDITECH CO., LTD.
25041 FARRIER CIRCLE
LAGUNA HILLS, CA 92653 US
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Contact
HENRY YANG
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
08/30/2007
Decision Date
11/01/2007
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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