FDA 510(k) Application Details - K173319

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K173319
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Aribex 11727 Fruehauf Drive Charlotte, NC 28273 US Other 510(k) Applications for this Company
Contact	Erika Martin 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	10/20/2017
Decision Date	11/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review