FDA 510(k) Application Details - K980946

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K980946
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	DENTSLEEVE PTY., LTD. 56 A/B GLEN OSMOND RD. PARKSIDE SOUTH AUSTRALIA 5063 AU Other 510(k) Applications for this Company
Contact	MARCUS TIPPETT 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	03/13/1998
Decision Date	06/08/1998
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