FDA 510(k) Application Details - K210751

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K210751
Device Name	Dressing, Wound, Drug
Applicant	BC3 Technologies Inc 3701-A Southwestern Blvd Baltimore, MD 21229 US Other 510(k) Applications for this Company
Contact	Wayne L. Grube 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	03/12/2021
Decision Date	02/02/2023
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