FDA 510(k) Application Details - K023641

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K023641
Device Name Filter, Bacterial, Breathing-Circuit
Applicant DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM, MA 02492 US
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Contact JOEL C KENT
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 10/30/2002
Decision Date 11/27/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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