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FDA 510(k) Application Details - K021265
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K021265
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM, MA 02492 US
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Contact
JOEL C KENT
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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
04/22/2002
Decision Date
08/30/2002
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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