FDA 510(k) Application Details - K052194

Device Classification Name	Mini Endoscope, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K052194
Device Name	Mini Endoscope, Gastroenterology-Urology
Applicant	BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	ALLYSON BARFORD Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2005
Decision Date	08/24/2005
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	Y
Expedited Review