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FDA 510(k) Application Details - K043160
Device Classification Name
Tube Tracheostomy And Tube Cuff
More FDA Info for this Device
510(K) Number
K043160
Device Name
Tube Tracheostomy And Tube Cuff
Applicant
TRACOE MEDICAL GMBH
117 FLANDERS ROAD
WESTBOROUGH, MA 01581 US
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Contact
MICHAEL A WARREN
Other 510(k) Applications for this Contact
Regulation Number
868.5800
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Classification Product Code
JOH
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More FDA Info for this Product Code
Date Received
11/15/2004
Decision Date
02/18/2005
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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