FDA 510(k) Application Details - K153259

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K153259
Device Name	Clamp, Vascular
Applicant	FORGE MEDICAL, INC. 701 W BROAD ST, SUITE 102 Bethlehem, PA 18018 US Other 510(k) Applications for this Company
Contact	Timothy Clark Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	DXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2015
Decision Date	01/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review