FDA 510(k) Application Details - K981322

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K981322
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. FALL RIVER, MA 02720-4740 US Other 510(k) Applications for this Company
Contact	JIM KENNEY 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	04/10/1998
Decision Date	07/07/1998
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