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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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More FDA Info for this Product Code
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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