FDA 510(k) Application Details - K210616

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K210616
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
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	882.5330   More FDA Info for this Regulation Number
Classification Product Code	GXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2021
Decision Date	03/31/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review