FDA 510(k) Application Details - K151308

Device Classification Name	Kit, Nephroscope   More FDA Info for this Device
510(K) Number	K151308
Device Name	Kit, Nephroscope
Applicant	SCHOELLY FIBEROPTIC, GMBH ROBERT-BOSCH-STR. 1-3 DENZLINGEN 79211 DE Other 510(k) Applications for this Company
Contact	SANDRA BAUMANN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FGA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2015
Decision Date	02/09/2016
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