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FDA 510(k) Application Details - K143356
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K143356
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
Ceterix Orthopaedics, Inc.
959 Hamilton Ave
Menlo Park, CA 94025 US
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Contact
Michael Hendricksen
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Regulation Number
878.5000
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Classification Product Code
GAT
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More FDA Info for this Product Code
Date Received
11/24/2014
Decision Date
07/21/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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