FDA 510(k) Application Details - K973797

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K973797
Device Name Filter, Bacterial, Breathing-Circuit
Applicant KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE, IN 46060 US
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Contact BRUCE E GREEN
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 10/06/1997
Decision Date 03/12/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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