FDA 510(k) Application Details - K181455

Device Classification Name	Booth, Sun Tan   More FDA Info for this Device
510(K) Number	K181455
Device Name	Booth, Sun Tan
Applicant	ProSun International LLC 2442 23rd Street North Saint Petersburg, FL 33713 US Other 510(k) Applications for this Company
Contact	Tom Henkemans 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	06/04/2018
Decision Date	09/10/2018
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