FDA 510(k) Application Details - K970110

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K970110
Device Name	Endoscope Channel Accessory
Applicant	BARD MEDICAL DIV. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US Other 510(k) Applications for this Company
Contact	DONNA J WILSON Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/1997
Decision Date	02/19/1997
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