FDA 510(k) Application Details - K163659

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K163659
Device Name	Apparatus, Exhaust, Surgical
Applicant	I.C MEDICAL, INC. 2340 W. SHANGRI LA RD. PHOENIX, AZ 85029 US Other 510(k) Applications for this Company
Contact	ELENA S. BUIGA Other 510(k) Applications for this Contact
Regulation Number	878.5070   More FDA Info for this Regulation Number
Classification Product Code	FYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2016
Decision Date	10/30/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review