FDA 510(k) Application Details - K964369

Device Classification Name	Catheters, Suction, Tracheobronchial   More FDA Info for this Device
510(K) Number	K964369
Device Name	Catheters, Suction, Tracheobronchial
Applicant	BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. DRAPER, UT 84020 US Other 510(k) Applications for this Company
Contact	E. MARTIN CHAMBERLAIN, JR. 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	11/01/1996
Decision Date	02/11/1997
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