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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, Polypropylene
510(k) Number K211178
Device Name DURAMESH Mesh Suture
Applicant
MSi
One Magnificent Mile
980 N. Lake Shore Drive, Suite 1400
Chicago,  IL  60611
Applicant Contact Greg Dumanian
Correspondent
MSi
One Magnificent Mile
980 N. Lake Shore Drive, Suite 1400
Chicago,  IL  60611
Correspondent Contact Greg Dumanian
Regulation Number878.5010
Classification Product Code
GAW  
Date Received04/20/2021
Decision Date 09/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03940560
Reviewed by Third Party No
Combination Product No
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