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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 K203186
Device Name DYNATAPE Suture
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH CH 2400
Applicant Contact Tatyana Korsunsky
DePuy Mitek, a Johnson and Johnson company
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Tatyana Korsunsky
Regulation Number878.5000
Classification Product Code
Date Received10/27/2020
Decision Date 03/18/2021
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