FDA 510(k) Application Details - K132268

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K132268
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH 100 DENNIS DRIVE READING, PA 19606 US Other 510(k) Applications for this Company
Contact	KIRSTEN STOWELL 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	07/22/2013
Decision Date	08/23/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review