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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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