FDA 510(k) Application Details - K000539

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K000539
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 40 HILLTOP DR. SYOSSET, NY 11791 US Other 510(k) Applications for this Company
Contact	RICHARD KUO 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	02/17/2000
Decision Date	04/27/2000
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review