FDA 510(k) Application Details - K011077

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K011077
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	ANDERSEN PRODUCTS, INC. 3202 CAROLINE DR., HEALTH SCIENCE PARK HAW RIVER, NC 27258-8710 US Other 510(k) Applications for this Company
Contact	WENDY HEDRICK 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	04/09/2001
Decision Date	05/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review