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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K143356
Device Name NovoStitch Plus Meniscal Repair System
Applicant
Ceterix Orthopaedics, Inc.
959 Hamilton Ave
Menlo Park,  CA  94025
Applicant Contact Michael Hendricksen
Correspondent
Ceterix Orthopaedics, Inc.
959 Hamilton Ave
Menlo Park,  CA  94025
Correspondent Contact Michael Hendricksen
Regulation Number878.5000
Classification Product Code
GAT  
Date Received11/24/2014
Decision Date 07/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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