FDA 510(k) Application Details - K971354

Device Classification Name	Tube, Double Lumen For Intestinal Decompression And/Or Intubation   More FDA Info for this Device
510(K) Number	K971354
Device Name	Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Applicant	MICHAEL M. KNOTT, M.D. 355 PINE ROSE CT. TAHOE CITY, CA 96145 US Other 510(k) Applications for this Company
Contact	MICHAEL M KNOTT Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	FEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/1997
Decision Date	11/19/1997
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