FDA 510(k) Application Details - K121173

Device Classification Name	More FDA Info for this Device
510(K) Number	K121173
Device Name	CHORD-X EPTFE SUTURE
Applicant	ON-XLIFETECHNOLOGIES 1300 EAST ANDERSON LANE BLDG B AUSTIN, TX 78752 US Other 510(k) Applications for this Company
Contact	JOHN ELY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2012
Decision Date	08/16/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review