FDA 510(k) Application Details - K113679

Device Classification Name	Led Light Source   More FDA Info for this Device
510(K) Number	K113679
Device Name	Led Light Source
Applicant	MAQUET SAS 45 BARBOUR POND DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	WHITNEY TORNING 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	12/14/2011
Decision Date	01/12/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review