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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, Steel, Monofilament And Multifilament, Sterile
510(k) Number K141007
Device Name DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
Applicant
Demetech Corp.
14175 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact ANTHONY DIMERCURIO
Correspondent
Demetech Corp.
14175 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact ANTHONY DIMERCURIO
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received04/18/2014
Decision Date 09/25/2014
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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