FDA 510(k) Application Details - K981910

Device Classification Name	Catheters, Suction, Tracheobronchial   More FDA Info for this Device
510(K) Number	K981910
Device Name	Catheters, Suction, Tracheobronchial
Applicant	NI-MED, INC. 1601 AIR PARK DR. P.O. BOX 871 FARMINGTON, MO 63640 US Other 510(k) Applications for this Company
Contact	MICHAEL GIBLIN Other 510(k) Applications for this Contact
Regulation Number	868.6810   More FDA Info for this Regulation Number
Classification Product Code	BSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/1998
Decision Date	08/24/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review