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FDA 510(k) Application Details - K192120
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K192120
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
Venner Medical (Singapore) Pte Ltd
35 Joo Koon Circle
Singapore 629110 SG
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Contact
Adrian P Waterton
Other 510(k) Applications for this Contact
Regulation Number
868.5730
More FDA Info for this Regulation Number
Classification Product Code
BTR
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More FDA Info for this Product Code
Date Received
08/06/2019
Decision Date
02/14/2020
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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