FDA 510(k) Application Details - K050503

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K050503
Device Name	Kit, Needle, Biopsy
Applicant	OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. MELVILLE, NY 11747-9058 US Other 510(k) Applications for this Company
Contact	LARUA STORMS-TYLER 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	02/28/2005
Decision Date	05/12/2005
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