FDA 510(k) Application Details - K991191

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K991191
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
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	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/1999
Decision Date	06/22/1999
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