FDA 510(k) Application Details - K152423

Device Classification Name	Booth, Sun Tan   More FDA Info for this Device
510(K) Number	K152423
Device Name	Booth, Sun Tan
Applicant	Sunfire Industries Inc. 4905 Highway 70 East New Bern, NC 28562 US Other 510(k) Applications for this Company
Contact	Doug Tyler Other 510(k) Applications for this Contact
Regulation Number	878.4635   More FDA Info for this Regulation Number
Classification Product Code	LEJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2015
Decision Date	05/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review