DEMETECH POLYESTER NONABSORBABLE SUTURE


Device Classification Name

suture, nonabsorbable, synthetic, polyethylene

510(k) Number K023030
Device Name DEMETECH POLYESTER NONABSORBABLE SUTURE
Original Applicant
DEMETECH CORP.
12119 sw 131 ave.
miami, 
FL 
33186

Original Contact luis arguello
Regulation Number 878.5000
Classification Product Code
GAT  
Date Received 09/11/2002
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