FDA 510(k) Application Details - K153472

Device Classification Name	Apparatus, Electrosurgical   More FDA Info for this Device
510(K) Number	K153472
Device Name	Apparatus, Electrosurgical
Applicant	ITL Corporation PTY LTD 1/63 Wells Road Chelsea Heights, VIC 3196 AU Other 510(k) Applications for this Company
Contact	Emily Rossiter Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	HAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2015
Decision Date	06/23/2016
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