FDA 510(k) Application Details - K964399

Device Classification Name	Device, Fixation, Tracheal Tube   More FDA Info for this Device
510(K) Number	K964399
Device Name	Device, Fixation, Tracheal Tube
Applicant	DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 PLAINVILLE, MA 02762 US Other 510(k) Applications for this Company
Contact	SHARON M STEEVES Other 510(k) Applications for this Contact
Regulation Number	868.5770   More FDA Info for this Regulation Number
Classification Product Code	CBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1996
Decision Date	01/28/1997
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