FDA 510(k) Application Details - K133311

Device Classification Name	Led Light Source   More FDA Info for this Device
510(K) Number	K133311
Device Name	Led Light Source
Applicant	OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	SHERI L MUSGNUNG Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2013
Decision Date	07/30/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review