FDA 510(k) Application Details - K101728

Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)

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510(K) Number K101728
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact SEAN WERNER
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 06/21/2010
Decision Date 08/25/2010
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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