FDA 510(k) Application Details - K962389

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K962389
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	UNOMEDICAL SDN BHD 40178 U.S. 19 NORTH TARPON SPRINGS, FL 34689 US Other 510(k) Applications for this Company
Contact	PATRICK J LAMB 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	06/20/1996
Decision Date	11/21/1996
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