FDA 510(k) Application Details - K982945

Device Classification Name	Catheters, Suction, Tracheobronchial   More FDA Info for this Device
510(K) Number	K982945
Device Name	Catheters, Suction, Tracheobronchial
Applicant	SPIRIT MEDICAL SYSTEMS, INC. 16267 WHITESTONE DR. PARKER, CO 80134 US Other 510(k) Applications for this Company
Contact	JEFF SAWYER 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	08/21/1998
Decision Date	09/22/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review