FDA 510(k) Application Details - K984374

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K984374
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	SAMYANG CORP. 200 GREGORY LANE, SUITE C-100 PLEASANT HILL, CA 94523-3389 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF 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	12/07/1998
Decision Date	06/04/1999
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