FDA 510(k) Application Details - K130191

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K130191
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	HANSBIOMED CORPORATION 325 N PUENTE ST UNIT B BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	APRIL LEE 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	01/25/2013
Decision Date	06/12/2013
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