FDA 510(k) Application Details - K972258

Device Classification Name Catheters, Suction, Tracheobronchial

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510(K) Number K972258
Device Name Catheters, Suction, Tracheobronchial
Applicant MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS, MO 63134 US
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Contact MICHAEL B SCHOECK
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Regulation Number 868.6810

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Classification Product Code BSY
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Date Received 06/17/1997
Decision Date 12/29/1997
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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