FDA 510(k) Application Details - K210839

Device Classification Name	More FDA Info for this Device
510(K) Number	K210839
Device Name	SoundBite Crossing System - Peripheral (14P)
Applicant	Soundbite Medical Solutions, Inc. 2300 Boulevard Alfred-Nobel Montreal H4S 2A4 CA Other 510(k) Applications for this Company
Contact	Dominique Abecassis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2021
Decision Date	04/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review