FDA 510(k) Application Details - K981891

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K981891
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	AMBU, INC. 611 NORTH HAMMONDS FERRY RD. LINTHICUM, MD 21090-1356 US Other 510(k) Applications for this Company
Contact	SANJAY H PARIKH Other 510(k) Applications for this Contact
Regulation Number	868.5730   More FDA Info for this Regulation Number
Classification Product Code	BTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/1998
Decision Date	07/17/1998
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