FDA 510(k) Application Details - K210006

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K210006
Device Name	Clamp, Vascular
Applicant	Biorep Technologies, Inc 15804 NW 57th Avenue Miami Lakes, FL 33014 US Other 510(k) Applications for this Company
Contact	Victoria Enjamio 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	01/04/2021
Decision Date	03/04/2021
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