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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
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