FDA 510(k) Application Details - K190367

Device Classification Name	More FDA Info for this Device
510(K) Number	K190367
Device Name	Smith & Nephew Tablet Application
Applicant	Smith & Nephew 150 Minuteman Road Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Janice Haselton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2019
Decision Date	05/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review