FDA 510(k) Application Details - K994001

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K994001
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. 157 WINDDANCE DR. CHICAGO, IL 60046 US Other 510(k) Applications for this Company
Contact	MAIN M GHAZAL Other 510(k) Applications for this Contact
Regulation Number	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/1999
Decision Date	02/09/2000
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