FDA 510(k) Application Details - K092733

Device Classification Name Cuff, Tracheal Tube, Inflatable

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510(K) Number K092733
Device Name Cuff, Tracheal Tube, Inflatable
Applicant ARM MEDICAL DEVICES, INC.
190 DINO ROAD
BRISTOL, CT 06010-7888 US
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Contact ANTHONY CALDERONI
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Regulation Number 868.5750

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Classification Product Code BSK
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Date Received 09/04/2009
Decision Date 02/26/2010
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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