FDA 510(k) Application Details - K071764

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K071764
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	OBTECH MEDICAL SARL 4545 CREEK RD. CINCINNATI, OH 45242 US Other 510(k) Applications for this Company
Contact	ELIZABETH MILLER Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2007
Decision Date	10/24/2007
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