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FDA 510(k) Application Details - K100950
Device Classification Name
Tube, Tracheostomy (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K100950
Device Name
Tube, Tracheostomy (W/Wo Connector)
Applicant
VENNER MEDICAL (SINGAPORE) PTE LTD
2626 VALLEY VIEW LANE,
SUITE 4
DALLAS, TX 75234 US
Other 510(k) Applications for this Company
Contact
JUDY BURTON
Other 510(k) Applications for this Contact
Regulation Number
868.5800
More FDA Info for this Regulation Number
Classification Product Code
BTO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2010
Decision Date
07/13/2010
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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