FDA 510(k) Application Details - K133200

Device Classification Name

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510(K) Number K133200
Device Name STALIF C(R)
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 OVE
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Date Received 10/17/2013
Decision Date 05/08/2014
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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