FDA 510(k) Application Details - K051361

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K051361
Device Name	Instrument, Biopsy
Applicant	BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	CHRISTINE M CAMERON Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2005
Decision Date	06/16/2005
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