FDA 510(k) Application Details - K212971

Device Classification Name	More FDA Info for this Device
510(K) Number	K212971
Device Name	NPseal
Applicant	Guard Medical Inc 1221 Brickwell Avenue, Suite 900 Miami, FL 33131 US Other 510(k) Applications for this Company
Contact	Machiel Van Der Leest Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2021
Decision Date	02/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review