FDA 510(k) Application Details - K112334

Device Classification Name	Electrosurgical Coagulation For Aesthetic   More FDA Info for this Device
510(K) Number	K112334
Device Name	Electrosurgical Coagulation For Aesthetic
Applicant	REFINE USA, LLC 340 3RD AVENUE SOUTH SUITE C JACKSONVILLE BEACH, FL 32250 US Other 510(k) Applications for this Company
Contact	BRIAN SMITH Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	ONQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2011
Decision Date	05/08/2012
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