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FDA 510(k) Application Details - K142378
Device Classification Name
More FDA Info for this Device
510(K) Number
K142378
Device Name
Interspinous Plate System
Applicant
Precision Spine, Inc.
5 Sylvan Way
Ste. 220
Parsippany, NJ 07930 US
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Contact
Michael C. Dawson
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Regulation Number
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Classification Product Code
PEK
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Date Received
08/26/2014
Decision Date
12/18/2014
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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