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FDA 510(k) Application Details - K151863
Device Classification Name
More FDA Info for this Device
510(K) Number
K151863
Device Name
Precision Spine Interspinous Plate System
Applicant
PRECISION SPINE, INC.
5 SYLVAN WAY, SUITE 220
PARSIPPANY, NJ 07930 US
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Contact
MICHAEL C. DAWSON
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEK
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More FDA Info for this Product Code
Date Received
07/08/2015
Decision Date
08/07/2015
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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