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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 K190777
Device Name DemeTECH DemeFORCE Nonabsorbable Surgical Suture
Applicant
DemeTECH Corporation
14175 NW 60th Ave
Miami Lakes,  FL  33014
Applicant Contact Tracy Chadwrick
Correspondent
DemeTECH Corporation
14175 NW 60th Ave
Miami Lakes,  FL  33014
Correspondent Contact Tracy Chadwrick
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/26/2019
Decision Date 07/31/2019
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 No
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