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FDA 510(k) Application Details - K083451
Device Classification Name
Filter, Conduction, Anesthetic
More FDA Info for this Device
510(K) Number
K083451
Device Name
Filter, Conduction, Anesthetic
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE, NH 03431 US
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Contact
CYNTHIA ENGELHARDT
Other 510(k) Applications for this Contact
Regulation Number
868.5130
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Classification Product Code
BSN
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More FDA Info for this Product Code
Date Received
11/21/2008
Decision Date
03/04/2009
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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