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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, surgical, absorbable, polydioxanone
510(k) Number K181582
Device Name DemeTECH DemeDIOX absorbable surgical suture
Applicant
Demetech Corporation
14175 NW 60th Ave
Miami Lakes,  FL  33014
Applicant Contact Linda Hernandez
Correspondent
Demetech Corporation
14175 NW 60th Ave
Miami Lakes,  FL  33014
Correspondent Contact Linda Hernandez
Regulation Number878.4840
Classification Product Code
NEW  
Date Received06/15/2018
Decision Date 08/27/2018
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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