FDA 510(k) Application Details - K083451

Device Classification Name Filter, Conduction, Anesthetic

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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
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Regulation Number 868.5130

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Classification Product Code BSN
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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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