FDA 510(k) Application Details - K134055

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K134055
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	DEXCOWIN CO., LTD 110 EAST GRANADA BLVD. SUITE 207 ORMOND BEACH, FL 32176 US Other 510(k) Applications for this Company
Contact	Claude Berthoin Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2013
Decision Date	05/09/2014
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