FDA 510(k) Application Details - K963064

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K963064
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	LABORIE MEDICAL TECH CORP. 6 HURRICANE LANE, #2 WILLISTON, VT 05495 US Other 510(k) Applications for this Company
Contact	THOMAS HIRTE Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/1996
Decision Date	06/05/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review