FDA 510(k) Application Details - K250708

Device Classification Name	More FDA Info for this Device
510(K) Number	K250708
Device Name	NPseal
Applicant	Guard Medical, Inc. 1221 Brickell 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	03/10/2025
Decision Date	04/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review