FDA 510(k) Application Details - K032878

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K032878
Device Name Filter, Bacterial, Breathing-Circuit
Applicant KUNG SHIN PLASTICS CO., LTD.
NO.58 FU-CHIUN ST
HSIN-CHU CITY 300 TW
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Contact JEN KE-MIN
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 09/15/2003
Decision Date 09/20/2004
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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