FDA 510(k) Application Details - K023028

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K023028
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	DEMETECH CORP. 12119 SW 131 AVE. MIAMI, FL 33186 US Other 510(k) Applications for this Company
Contact	LUIS ARGUELLO Other 510(k) Applications for this Contact
Regulation Number	878.5020   More FDA Info for this Regulation Number
Classification Product Code	GAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2002
Decision Date	06/18/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review