FDA 510(k) Application Details - K962240

Device Classification Name Tube, Tracheostomy (W/Wo Connector)

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510(K) Number K962240
Device Name Tube, Tracheostomy (W/Wo Connector)
Applicant BOSTON MEDICAL PRODUCTS, INC.
117 FLANDERS RD.
WESTBOROUGH, MA 01581 US
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Contact STUART K MONTGOMERY
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Regulation Number 868.5800

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Classification Product Code BTO
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Date Received 06/11/1996
Decision Date 08/15/1996
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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