FDA 510(k) Application Details - K170967

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K170967
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Skanray Technologies Private Limited Plot 15-17, Hebbal Industrial Area Mysore 570016 IN Other 510(k) Applications for this Company
Contact	Mahadevan J. 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	03/31/2017
Decision Date	06/08/2017
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
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