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FDA 510(k) Application Details - K133286
Device Classification Name
More FDA Info for this Device
510(K) Number
K133286
Device Name
MIDLINE (TM)
Applicant
CENTINEL SPINE, INC.
900 AIRPORT RD, STE #3B
WEST CHESTER, PA 19380 US
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Contact
JOHN PARRY
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Regulation Number
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Classification Product Code
OVD
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Date Received
10/25/2013
Decision Date
01/09/2014
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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