FDA 510(k) Application Details - K063071

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

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510(K) Number K063071
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE, CA 94089 US
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Contact CINDY DOMECUS
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 10/06/2006
Decision Date 04/13/2007
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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