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FDA 510(k) Application Details - K981080
Device Classification Name
Tube, Tracheostomy (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K981080
Device Name
Tube, Tracheostomy (W/Wo Connector)
Applicant
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact
LESIS WARD
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Regulation Number
868.5800
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Classification Product Code
BTO
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More FDA Info for this Product Code
Date Received
03/24/1998
Decision Date
06/17/1998
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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