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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 K193530
Device Name Deklene MAXX
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 Number878.5010
Classification Product Code
GAW  
Date Received12/20/2019
Decision Date 03/19/2020
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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