FDA 510(k) Application Details - K163026

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K163026
Device Name	Media,Coupling,Ultrasound
Applicant	Pharmaceutical Innovations Inc. 897 Frelinghuysen Ave. Newark, NJ 07114 US Other 510(k) Applications for this Company
Contact	Shirley J. Bergman Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	MUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2016
Decision Date	01/09/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review