FDA 510(k) Application Details - K964131

Device Classification Name	Sigmoidoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K964131
Device Name	Sigmoidoscope And Accessories, Flexible/Rigid
Applicant	AKOS BIOMEDICAL, INC. 6450 LUSK BLVD., SUITE 109 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	LACYNE Y AVERY 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	10/15/1996
Decision Date	06/27/1997
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