FDA 510(k) Application Details - K113004

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K113004
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 SOMERVILLE, NJ 08876-0151 US Other 510(k) Applications for this Company
Contact	PETER CECCHINI Other 510(k) Applications for this Contact
Regulation Number	878.4840   More FDA Info for this Regulation Number
Classification Product Code	NEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2011
Decision Date	12/20/2011
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