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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K130083
Device Name DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
Applicant
Demetech Corp.
14175 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact ANTHONY J DIMERCURIO
Correspondent
Demetech Corp.
14175 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact ANTHONY J DIMERCURIO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received01/14/2013
Decision Date 07/17/2013
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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