FDA 510(k) Application Details - K093408

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K093408
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. NORTH HAVEN, CT 06473 US Other 510(k) Applications for this Company
Contact	NISHITH DESAI 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	11/02/2009
Decision Date	11/12/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review