FDA 510(k) Application Details - K212521

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K212521
Device Name	Dressing, Wound, Drug
Applicant	Kericure Inc. 26620 Easy St Wesley Chapel, FL 33544 US Other 510(k) Applications for this Company
Contact	Kerriann Greenhalgh 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	08/10/2021
Decision Date	07/18/2024
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