FDA 510(k) Application Details - K093426

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K093426
Device Name Filter, Bacterial, Breathing-Circuit
Applicant PHARMA SYSTEMS AB
24301 WOODSAGE DR.
BONITA SPRINGS, FL 34134 US
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Contact PAUL DRYDEN
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 11/03/2009
Decision Date 02/22/2010
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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