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FDA 510(k) Application Details - K072002
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K072002
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford, PA 18969 US
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Contact
KATHY ANDERSON
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Regulation Number
868.5260
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Classification Product Code
CAH
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Date Received
07/23/2007
Decision Date
01/31/2008
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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