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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, synthetic, polyethylene
510(k) Number K023030
Device Name DEMETECH POLYESTER NONABSORBABLE SUTURE
Applicant
DEMETECH CORP.
12119 SW 131 AVE.
MIAMI,  FL  33186
Applicant Contact LUIS ARGUELLO
Correspondent
DEMETECH CORP.
12119 SW 131 AVE.
MIAMI,  FL  33186
Correspondent Contact LUIS ARGUELLO
Regulation Number878.5000
Classification Product Code
GAT  
Date Received09/11/2002
Decision Date 06/18/2003
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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