FDA 510(k) Application Details - K962078

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K962078
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	CONTINENTAL MEDICAL LABORATORIES, INC. 817 W.MOHR AVE. P.O. BOX 306 WATERFORD, WI 53185 US Other 510(k) Applications for this Company
Contact	JOSEPH DUNN 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	05/28/1996
Decision Date	10/11/1996
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review