FDA 510(k) Application Details - K182776

Device Classification Name	More FDA Info for this Device
510(K) Number	K182776
Device Name	Neocis Guidance System
Applicant	Neocis Inc. 555 NW 29th ST Miami, FL 33127 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	10/01/2018
Decision Date	12/21/2018
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