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FDA 510(k) Application Details - K100283
Device Classification Name
Tube, Tracheostomy (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K100283
Device Name
Tube, Tracheostomy (W/Wo Connector)
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 US
Other 510(k) Applications for this Company
Contact
SUSANNE GALIN
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
02/01/2010
Decision Date
04/23/2010
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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