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FDA 510(k) Application Details - K092029
Device Classification Name
Attachment, Breathing, Positive End Expiratory Pressure
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510(K) Number
K092029
Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford, PA 18969 US
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Contact
JOYCE KILROY
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Regulation Number
868.5965
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Classification Product Code
BYE
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More FDA Info for this Product Code
Date Received
07/06/2009
Decision Date
08/06/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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