FDA 510(k) Application Details - K972478

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K972478
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	APPLIED MEDICAL TECHNOLOGIES 6551 BRECKSVILLE RD. INDEPENDENCE, OH 44131 US Other 510(k) Applications for this Company
Contact	THOMAS W PARKINSON 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	07/01/1997
Decision Date	02/09/1998
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