FDA 510(k) Application Details - K211014

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K211014
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Surround Medical Systems 175 Southport Dr, Suite 900 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Elizabeth Sullivan Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2021
Decision Date	07/28/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review