FDA 510(k) Application Details - K990428

Device Classification Name	Bag, Bile Collecting   More FDA Info for this Device
510(K) Number	K990428
Device Name	Bag, Bile Collecting
Applicant	REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. ALPHARETTA, GA 30005 US Other 510(k) Applications for this Company
Contact	STEVE WOODY Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	EXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/1999
Decision Date	08/12/1999
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