FDA 510(k) Application Details - K211514

Device Classification Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction   More FDA Info for this Device
510(K) Number	K211514
Device Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Applicant	Longeviti Neuro Solutions, LLC 303 International Circle Suite 190 Hunt Valley, MD 21030 US Other 510(k) Applications for this Company
Contact	Heather Hourihan Other 510(k) Applications for this Contact
Regulation Number	878.3500   More FDA Info for this Regulation Number
Classification Product Code	KKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2021
Decision Date	07/15/2021
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