DEMETECH SILK NONABSORBABLE SUTURE


Device Classification Name

suture, nonabsorbable, silk

510(k) Number K023029
Device Name DEMETECH SILK NONABSORBABLE SUTURE
Original Applicant
DEMETECH CORP.
12119 sw 131 ave.
miami, 
FL 
33186

Original Contact luis arguello
Regulation Number 878.5030
Classification Product Code
GAP  
Date Received 09/11/2002
Decision Date 11/25/2002
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