FDA 510(k) Application Details - K161906

Device Classification Name	More FDA Info for this Device
510(K) Number	K161906
Device Name	SCIg60 Infuser
Applicant	EMED TECHNOLOGIES CORPORATION 1264 Hawks Flight Ct, Ste. 200 EL DORADO HILLS, CA 95762 US Other 510(k) Applications for this Company
Contact	PETER KOLLINGS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2016
Decision Date	12/01/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review