FDA 510(k) Application Details - K955680

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K955680
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 ST. LOUIS, MO 63134 US Other 510(k) Applications for this Company
Contact	MICHAEL B SCHOECK Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	JOH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/1995
Decision Date	03/13/1996
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