FDA 510(k) Application Details - K153096

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K153096
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	SentreHEART, Inc. 300 Saginaw Drive Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	KIT CARIQUITAN Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2015
Decision Date	11/25/2015
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