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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 K181633
Device Name MTF Pre-Sutured Tendon
Applicant
Musculoskeletal Transplant Foundation
125 May Street
Edison,  NJ  08837
Applicant Contact Katrina Carroll
Correspondent
Musculoskeletal Clinical Reulatory Advisers, LLC
125 May Street
Edison,  NJ  08837
Correspondent Contact Katrina Carroll
Regulation Number878.5000
Classification Product Code
GAT  
Date Received06/20/2018
Decision Date 03/15/2019
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 Yes
Recalls CDRH Recalls
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