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FDA 510(k) Application Details - K100546
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K100546
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
PARKERMEDICALINC
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact
LEWIS WARD
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
02/25/2010
Decision Date
06/03/2010
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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