FDA 510(k) Application Details - K964111

Device Classification Name	Evacuator, Gastro-Urology   More FDA Info for this Device
510(K) Number	K964111
Device Name	Evacuator, Gastro-Urology
Applicant	ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE Other 510(k) Applications for this Contact
Regulation Number	876.4370   More FDA Info for this Regulation Number
Classification Product Code	KQT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/1996
Decision Date	12/16/1996
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