FDA 510(k) Application Details - K213552

Device Classification Name	More FDA Info for this Device
510(K) Number	K213552
Device Name	PuraStat-RM
Applicant	3-D Matrix, Inc. 1234 Chestnut St., Suite 205 Newton, MA 02464 US Other 510(k) Applications for this Company
Contact	Lisa Spirio Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2021
Decision Date	04/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review