FDA 510(k) Application Details - K014281

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K014281
Device Name Filter, Bacterial, Breathing-Circuit
Applicant MUNKTELL FILTER AB
6329 W. WATERVIEW CT.
MCCORDSVILLE, IN 46055-9501 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 12/27/2001
Decision Date 06/26/2002
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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