FDA 510(k) Application Details - K032716

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K032716
Device Name Filter, Bacterial, Breathing-Circuit
Applicant PORTEX LTD.
MILITARY ROAD
HYTHE, KENT CT 21 6JL GB
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Contact STEVE OGILVIE
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 09/02/2003
Decision Date 11/28/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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