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FDA 510(k) Application Details - K112915
Device Classification Name
Cuff, Tracheal Tube, Inflatable
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510(K) Number
K112915
Device Name
Cuff, Tracheal Tube, Inflatable
Applicant
SPIRITUS TECHNOLOGIES LLC
12005 W. 100TH TERRACE
LENEXA, KS 66215 US
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Contact
BRANDON W CLOSE
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Regulation Number
868.5750
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Classification Product Code
BSK
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Date Received
10/03/2011
Decision Date
05/25/2012
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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