FDA 510(k) Application Details - K161394

Device Classification Name	Booth, Sun Tan   More FDA Info for this Device
510(K) Number	K161394
Device Name	Booth, Sun Tan
Applicant	Sportarredo Group S.C. Via dell' Industria 7 Gruaro 30020 IT Other 510(k) Applications for this Company
Contact	STEFANO IRIDIO 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	05/19/2016
Decision Date	07/06/2017
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