FDA 510(k) Application Details - K203401

Device Classification Name	More FDA Info for this Device
510(K) Number	K203401
Device Name	Neocis Guidance System (NGS) with Patient Splints (EPS)
Applicant	Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami, FL 33317 US Other 510(k) Applications for this Company
Contact	Thomas E. Claiborne Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2020
Decision Date	12/15/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review