FDA 510(k) Application Details - K061426

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K061426
Device Name Filter, Bacterial, Breathing-Circuit
Applicant POROUS MEDIA CORP.
1350 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact DAVID RASCH
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 05/23/2006
Decision Date 06/05/2006
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 Y
Expedited Review



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