FDA 510(k) Application Details - K042367

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K042367
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	AROS SURGICAL INSTRUMENTS CORP. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GRACE HOLLAND 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	08/31/2004
Decision Date	10/14/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review