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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, natural
510(k) Number K072930
Device Name DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
Applicant
DEMETECH CORP.
3530 N.W. 115TH AVE.
MIAMI,  FL  33178
Applicant Contact A.J. DIMERCURIO
Correspondent
DEMETECH CORP.
3530 N.W. 115TH AVE.
MIAMI,  FL  33178
Correspondent Contact A.J. DIMERCURIO
Regulation Number878.4830
Classification Product Code
GAL  
Date Received10/16/2007
Decision Date 04/30/2008
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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