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FDA 510(k) Application Details - K173912
Device Classification Name
Tube Tracheostomy And Tube Cuff
More FDA Info for this Device
510(K) Number
K173912
Device Name
Tube Tracheostomy And Tube Cuff
Applicant
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis, MN 55442 US
Other 510(k) Applications for this Company
Contact
Donna M. Semlak
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
12/22/2017
Decision Date
05/08/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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