FDA 510(k) Application Details - K031997

Device Classification Name Catheters, Suction, Tracheobronchial

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510(K) Number K031997
Device Name Catheters, Suction, Tracheobronchial
Applicant MALLINCKRODT DAR S.R.L.
VIA G.BOVE, 2/4/6/8
MIRANDOLA (MODENA) 41037 IT
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Contact GIUSEPPE TOMASINI
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Regulation Number 868.6810

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Classification Product Code BSY
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Date Received 06/27/2003
Decision Date 11/25/2003
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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