FDA 510(k) Application Details - K964326

Device Classification Name	Sigmoidoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K964326
Device Name	Sigmoidoscope And Accessories, Flexible/Rigid
Applicant	VISION-SCIENCES, INC. 6 STRATHMORE RD. NATICK, MA 01760 US Other 510(k) Applications for this Company
Contact	PAMELA PAPINEAU Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/1996
Decision Date	01/03/1997
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