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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 K192490
Device Name Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
Applicant
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact Robin Haden
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Robin Haden
Regulation Number878.5000
Classification Product Code
GAT  
Date Received09/11/2019
Decision Date 03/30/2020
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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