FDA 510(k) Application Details - K151738

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K151738
Device Name	Kit, Needle, Biopsy
Applicant	OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JP Other 510(k) Applications for this Company
Contact	TOSHIYUKI NAKAJIMA Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2015
Decision Date	11/20/2015
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