FDA 510(k) Application Details - K072470

Device Classification Name	Suture, Recombinant Technology   More FDA Info for this Device
510(K) Number	K072470
Device Name	Suture, Recombinant Technology
Applicant	ENTRIGUE SURGICAL, INC. 3463 MAGIC DRIVE, SUITE 320 SAN ANTONIO, TX 78229 US Other 510(k) Applications for this Company
Contact	GABRIELE NIEDERAUER Other 510(k) Applications for this Contact
Regulation Number	878.4494   More FDA Info for this Regulation Number
Classification Product Code	NWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2007
Decision Date	11/16/2007
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