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FDA 510(k) Application Details - K030071
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K030071
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
MAQUET, INC.
1140 ROUTE 22 EAST
SUITE 202
BRIDGEWATER, NJ 08807 US
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Contact
JAMIE YIEH
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Regulation Number
868.5260
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Classification Product Code
CAH
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Date Received
01/08/2003
Decision Date
04/26/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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