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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 K191361
Device Name DemeDIOX Barbed Absorbable 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 Number878.4840
Classification Product Code
NEW  
Date Received05/21/2019
Decision Date 11/07/2019
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
Predetermined Change
Control Plan Authorized		 No
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