FDA 510(k) Application Details - K161358

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K161358
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	SURGICAL INSTRUMENT SERVICE AND SAVINGS INC 2747 SW 6TH ST. REDMOND, OR 97756 US Other 510(k) Applications for this Company
Contact	BRANDI J. PANTELEON Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2016
Decision Date	08/03/2017
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