FDA 510(k) Application Details - K022666

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K022666
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 1591 S. MOORLAND RD. SUITE 104 NEW BERLIN, WI 53151 US Other 510(k) Applications for this Company
Contact	CHARLES F ANDREWS Other 510(k) Applications for this Contact
Regulation Number	878.4840   More FDA Info for this Regulation Number
Classification Product Code	NEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2002
Decision Date	10/09/2002
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