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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 K180531
Device Name NovoStitch Pro Meniscal Repair System
Applicant
Ceterix Orthopaedics, Inc.
6500 Kaiser Drive, Suite 120
Fremont,  CA  94555
Applicant Contact Tarhan Kayihan
Correspondent
QRAC,LLC
6500 Kaiser Drive, Suite 120
Fremont,  CA  94555
Correspondent Contact Debra Cogan
Regulation Number878.5000
Classification Product Code
GAT  
Date Received02/28/2018
Decision Date 03/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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