FDA 510(k) Application Details - K962045

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K962045
Device Name Filter, Bacterial, Breathing-Circuit
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 868.5260

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Classification Product Code CAH
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Date Received 05/28/1996
Decision Date 11/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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