FDA 510(k) Application Details - K222025

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K222025
Device Name	Dressing, Wound, Drug
Applicant	Gel4Med, Inc. 1660 Soldiers Field Rd STE 7 #1063 Brighton, MA 02135 US Other 510(k) Applications for this Company
Contact	Ana Tellechea Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2022
Decision Date	10/11/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review