FDA 510(k) Application Details - K092657

Device Classification Name Anesthesia Conduction Kit

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510(K) Number K092657
Device Name Anesthesia Conduction Kit
Applicant SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE, NH 03431 US
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Contact CINDY ENGELHARDT
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Regulation Number 868.5140

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Classification Product Code CAZ
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Date Received 08/28/2009
Decision Date 11/04/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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