FDA 510(k) Application Details - K103813

Device Classification Name	Led Light Source   More FDA Info for this Device
510(K) Number	K103813
Device Name	Led Light Source
Applicant	SOPRO 124 GAITHER DRIVE SUITE 140 MT. LAUREL, NJ 08054 US Other 510(k) Applications for this Company
Contact	RICK ROSATI 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	12/29/2010
Decision Date	03/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review