FDA 510(k) Application Details - K191046

Device Classification Name	More FDA Info for this Device
510(K) Number	K191046
Device Name	L10 LED Light Source with AIM, L11 LED Light Source with AIM
Applicant	Stryker 5900 Optical Court San Jose, CA 95138 US Other 510(k) Applications for this Company
Contact	Agatha Szeliga Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2019
Decision Date	05/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review