FDA 510(k) Application Details - K151112

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K151112
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	ANGIOTECH 100 DENNIS DRIVE READING, PA 19606 US Other 510(k) Applications for this Company
Contact	HILARY WELLS Other 510(k) Applications for this Contact
Regulation Number	878.5010   More FDA Info for this Regulation Number
Classification Product Code	GAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2015
Decision Date	09/10/2015
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