FDA 510(k) Application Details - K192684

Device Classification Name	More FDA Info for this Device
510(K) Number	K192684
Device Name	HydroPearl Microspheres
Applicant	MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Analia Staubly Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2019
Decision Date	01/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review