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FDA 510(k) Application Details - K031997
Device Classification Name
Catheters, Suction, Tracheobronchial
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.6810
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Classification Product Code
BSY
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More FDA Info for this Product Code
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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