FDA 510(k) Application Details - K001434

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K001434
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. FALL RIVER, MA 02720-4740 US Other 510(k) Applications for this Company
Contact	MARY E GRAY Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2000
Decision Date	06/12/2000
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