FDA 510(k) Application Details - K123668

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K123668
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 US Other 510(k) Applications for this Company
Contact	TATYANA KORSUNSKY 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	11/29/2012
Decision Date	02/26/2013
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