FDA 510(k) Application Details - K953559

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

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510(K) Number K953559
Device Name Tube, Tracheostomy (W/Wo Connector)
Applicant SEIDEL MEDIZIN GMBH
16 STOCKDORFER WEG
BUCHENDORF D-82131 DE
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Contact MARTHA STRASSER
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Regulation Number 868.5800

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Classification Product Code BTO
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Date Received 06/20/1995
Decision Date 05/16/1996
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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